FDA 510(k), K911599, IMMUNOWELL LYME (P39 RECOMBINANT) TEST

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