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FDA 510(k), K141757, ALERE I STREP A
FDA 510(k), K141757, ALERE I STREP A
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$149.00 USD
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$149.00 USD
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510(K) Number: K141757
Device Name: ALERE I STREP A
Manufacturer: Angela Drysdale
Device Classification Name: Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
Regulation Number: PGX
Classification Product Code: 06/30/2014
Date Received: 03/31/2015
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Microbiology
Device Name: ALERE I STREP A
Manufacturer: Angela Drysdale
Device Classification Name: Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
Regulation Number: PGX
Classification Product Code: 06/30/2014
Date Received: 03/31/2015
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Microbiology
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