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Found 4 results
510(k) Data Aggregation
K Number
K081879Device Name
SPSMEDICAL SPORVIEW PA CULTURE SET
Manufacturer
SPS MEDICAL SUPPLY CORP.
Date Cleared
2008-07-30
(28 days)
Product Code
MRB
Regulation Number
880.2800Why did this record match?
Product Code :
MRB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SPSmedical SporView® PA Culture Set is intended for use with the STERIS System 1® sterilizer using STERIS® 20 sterilant only. The SporView® PA Culture Set provides independent confirmation that sterilization conditions were achieved during the STERIS System 10 processing cycle. A reduced incubation time of 16 hours has been wallated for the SporView® PA Culture Set using SPSmedical's SporView® culture media.
Device Description
SporView® PA Culture Set is intended to monitor the STERIS System 1 sterilization process, with STERIS® 20 sterilant. The product contains paper strips that are process, with G. stearothermophilus spores. Sterile tubes of SporView® Culture Media (modified soybean casein broth) and a transfer clip are included.
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K Number
K053212Device Name
RAVEN PROPACT
Manufacturer
RAVEN BIOLOGICAL LABORATORIES, INC.
Date Cleared
2006-02-15
(91 days)
Product Code
MRB
Regulation Number
880.2800Why did this record match?
Product Code :
MRB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Raven Pro-PACT Peracetic Acid Culture Test Kit is intended for use in testing the efficacy of Steris System1 <sup>TM</sup> , a liquid chemical sterilization system, processing cycles. A reduced incubation time of 24 hours has been validated for the Raven Pro-PACT Peracetic Acid Culture Test Kit.
Device Description
Not Found
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K Number
K043135Device Name
SPSMEDICAL SPORVIEW PA CULTURE SET
Manufacturer
SPS MEDICAL SUPPLY CORP.
Date Cleared
2005-01-13
(62 days)
Product Code
MRB
Regulation Number
880.2800Why did this record match?
Product Code :
MRB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SPSmedical SporView® PA Culture Set is intended for use with the STERIS System 1® sterilizer using STERIS® 20 sterilant only. The STERIS System 1® is a liquid chemical sterilization process. The SporView PA Culture Set provides independent confirmation that sterilization conditions were achieved during the STERIS System 1® processing cycle. A reduced incubation time of 24 hours has been validated for the Spor View PA Culture Set using SPSmedical's SporView® culture media.
Device Description
Spor View PA Culture Set is intended to monitor the STERIS System 1® peracetic acid sterilization process using the STERIS® 20 sterilant. The product contains paper strips the are inoculated with G. stearothermophilus spores (formally known as Bacillus stearothermonities) at a nominal population of 1 x 10 per strip. Sterile tubes of Spor View Culture Media mopiditied soybean casein broth) and a transfer clip are included. The product is intended to be uned in en identical manner as the Castle® SPOR-TEST PA Biological Indicator Kit.
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K Number
K031114Device Name
PRO-PACT PERACETIC ACID CULTURE TEST KIT, MODEL C-3PA
Manufacturer
RAVEN BIOLOGICAL LABORATORIES, INC.
Date Cleared
2004-03-03
(330 days)
Product Code
MRB
Regulation Number
880.2800Why did this record match?
Product Code :
MRB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Raven ProPACT Peracetic Acid Culture Test Kit is intended for use with STERIS SYSTEM 1™, a liquid chemical sterilization system. The ProPACT Peracetic Acid Culture Test Kit provides independent confirmation that sterilization conditions were achieved during the STERIS SYSTEM 1 processing cycle. A reduced incubation time of 48 hours has been validated for the Raven ProPACT Peracetic Acid Culture Test Kit.
Device Description
Not Found
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