FDA 510(k), K911627, IMMUNODOT BORRELIA (LYME) TEST

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