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FDA 510(k) K911599, IMMUNOWELL LYME (P39 RECOMBINANT) TEST, by General Biometrics, Inc.

FDA 510(k) K911599, IMMUNOWELL LYME (P39 RECOMBINANT) TEST, by General Biometrics, Inc.

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510(K) Number: K911599
Device Name: IMMUNOWELL LYME (P39 RECOMBINANT) TEST
Manufacturer: General Biometrics, Inc.
Device Classification Name: reagent, borrelia serological reagent
Regulation Number: 866.3830
Classification Product Code: LSR
Date Received: 04/09/1991
Decision Date: 12/30/1991
Regulation Medical Specialty: Microbiology

Total pages: 239
Fully redacted pages: 33
Content pages: 206
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