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FDA 510(k) K911627, IMMUNODOT BORRELIA (LYME) TEST, by General Biometrics, Inc.

FDA 510(k) K911627, IMMUNODOT BORRELIA (LYME) TEST, by General Biometrics, Inc.

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510(K) Number: K911627
Device Name: IMMUNODOT BORRELIA (LYME) TEST
Manufacturer: General Biometrics, Inc.
Device Classification Name: reagent, borrelia serological reagent
Regulation Number: 866.3830
Classification Product Code: LSR
Date Received: 04/11/1991
Decision Date: 04/08/1992
Regulation Medical Specialty: Microbiology

Total pages: 230
Fully redacted pages: 117
Content pages: 113
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