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Found 7 results

510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

SCANDINAVIAN IVF SCIENCES AB, G2.2

Manufacturer

VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB

Date Cleared

2000-06-27

(131 days)

Product Code

Regulation Number

Type

Panel

Obstetrics/Gynecology

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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K Number

Validate with FDA (Live)

Device Name

SCANDINAVIAN IVF SCIENCES AB, HYBASE-1

Manufacturer

VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB

Date Cleared

2000-06-13

(117 days)

Product Code

Regulation Number

Type

Panel

Obstetrics/Gynecology

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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K Number

Validate with FDA (Live)

Device Name

SCANDINAVIAN IVF SCIENCES AB, GAMETE-100

Manufacturer

VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB

Date Cleared

2000-05-23

(96 days)

Product Code

Regulation Number

Type

Panel

Obstetrics/Gynecology

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

Ask a Question

Ask a specific question about this device

K Number

Validate with FDA (Live)

Device Name

SCANDINAVIAN IVF SCIENCES AB, G1.2

Manufacturer

VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB

Date Cleared

2000-05-23

(96 days)

Product Code

Regulation Number

Type

Panel

Obstetrics/Gynecology

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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K Number

Validate with FDA (Live)

Device Name

SCANDINAVIAN IVF SCIENCES AB, THAW-KIT 1

Manufacturer

VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB

Date Cleared

2000-05-17

(90 days)

Product Code

Regulation Number

Type

Panel

Obstetrics/Gynecology

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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K Number

Validate with FDA (Live)

Device Name

SCANDINAVIAN IVF SCIENCES AB, FREEZE-KIT 1

Manufacturer

VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB

Date Cleared

2000-05-16

(89 days)

Product Code

Regulation Number

Type

Panel

Obstetrics/Gynecology

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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K Number

Validate with FDA (Live)

Device Name

SCANDINAVIAN IVF SCIENCES AB, SPERMRINSE -20/100

Manufacturer

VITROLIFE AB/SCANDINAVIAN IVF SCIENCES AB

Date Cleared

2000-05-16

(89 days)

Product Code

Regulation Number

Type

Panel

Obstetrics/Gynecology

Reference & Predicate Devices

N/A

Predicate For

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

Ask a Question

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