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FDA 510(k), K911599, IMMUNOWELL LYME (P39 RECOMBINANT) TEST
FDA 510(k), K911599, IMMUNOWELL LYME (P39 RECOMBINANT) TEST
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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
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
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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