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510(k) Data Aggregation
K Number
K023222Device Name
ISOCARE ONE STEP SPERM PROCESSING MEDIUM CAT# 2207-12
Manufacturer
INVITROCARE, INC.
Date Cleared
2002-12-26
(90 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
INVITROCARE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ISOCARE ONE-STEP Sperm Processing Medium is intended for use in assisted reproductive technology procedures that involve the isolation, processing and transfer of sperm. Specifically, ISOCARE ONE-STEP Sperm Processing Medium is intended for use as a sperm isolation and processing medium in the isolation and processing of sperm during intrauterine and other reproductive technology procedures.
Device Description
ISOCARE ONE-STEP Sperm Processing Medium is a synthetic, defined culture medium composed of a mixture of salts and other physiologically compatible substances supplemented with 5mg/ml human serum albumin. ISOCARE ONE-STEP Sperm Processing Medium is intended for use in sperm processing procedures prior to intrauterine or other assisted reproductive technology procedures. It has been formulated to mimic the composition of the fluid found in fallopian tubes as defined by Quinn etal (Quinn P, Kerin JF, Warnes GM: Fertil Steril 1985;44:493-498). ISOCARE ONE-STEP Medium uses a combined sodium bicarbonate/HEPES (J4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid () buffering system and is appropriate for those procedures that do not use a carbon dioxide atmosphere.
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K Number
K003751Device Name
HYALURONIDASE REAGENT, MODEL CAT#2212
Manufacturer
INVITROCARE, INC.
Date Cleared
2001-01-17
(43 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
INVITROCARE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K001967Device Name
PVP-POLYVINYLPYRROLIDONE REAGENT, MODEL CAT#2210
Manufacturer
INVITROCARE, INC.
Date Cleared
2000-08-14
(47 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
INVITROCARE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K001113Device Name
IVC THREE BLASTOCYST MEDIUM, CAT # 2007
Manufacturer
INVITROCARE, INC.
Date Cleared
2000-06-13
(68 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
INVITROCARE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000989Device Name
SPERM WASH MEDIUM, CAT# 2003/2005
Manufacturer
INVITROCARE, INC.
Date Cleared
2000-06-08
(72 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
INVITROCARE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000937Device Name
IVC TWO MEDIUM
Manufacturer
INVITROCARE, INC.
Date Cleared
2000-05-25
(63 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
INVITROCARE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000938Device Name
IVC ONE MEDIUM
Manufacturer
INVITROCARE, INC.
Date Cleared
2000-05-25
(63 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
INVITROCARE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K993484Device Name
Q-HTF, CAT# 2001
Manufacturer
INVITROCARE, INC.
Date Cleared
2000-05-25
(224 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
INVITROCARE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Q-HTF is intended for the retrieval, culture, transport, storage and transfer of human gametes and embryos.
Q-HTF Medium is intended for use in assisted reproductive technology procedures that involve the manipulation of gametes and embryos. Specifically, Q-HTF is intended for use a a culture medium for the embryo after fertilization, when used with an incubator, and as a nedim to support in vitro fertilization. Q-HTF is intended to simulate the substances fourd in the human to female reproductive system.
Device Description
Q-HTF is a synthetic, defined culture medium intended for use in assisted reproductive technology procedures. It has been formulated to mimic the composition of the fluid found in fallopian tubes as defined by Quinn etal (Quinn P, Kerin JF, Warnes GM: Fertil Steril 1985;44:493-498). Q-HTF uses a sodium bicarbonate buffering system and is appropriate for those procedures requiring the use of a carbon dioxide atmosphere during incubation.
Q-HTF is intended for use as a culture medium, with appropriate protein supplementation, for the support of fertilized embryos. Fertilization is also allowed to occur in Q-HTF when in vitro fertilization techniques are used. The fertilized gamete is then allowed to grow in the media and supplement, which are replenished as needed, until the desired state of development, usually up to three days post fertilization. Since Q-HTF utilizes a sodium bicarbonate buffer system, it is intended to be used in those procedures that require a carbon dioxide atmosphere, as is found in the incubators used by assisted reproductive laboratories. Therefore Q-HTF is primarily used as a medium to support embryo growth, development and culture in vitro.
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K Number
K000939Device Name
HTF-HEPES
Manufacturer
INVITROCARE, INC.
Date Cleared
2000-05-04
(42 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
INVITROCARE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000940Device Name
HUMAN SERUM ALBUMIN (HSA)
Manufacturer
INVITROCARE, INC.
Date Cleared
2000-05-04
(42 days)
Product Code
MQL
Regulation Number
884.6180Why did this record match?
Applicant Name (Manufacturer) :
INVITROCARE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
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