The following data is part of a premarket notification filed by General Biometrics, Inc. with the FDA for Immunowell Lyme (p39 Recombinant) Test.
| Device ID | K911599 |
| 510k Number | K911599 |
| Device Name: | IMMUNOWELL LYME (P39 RECOMBINANT) TEST |
| Classification | Reagent, Borrelia Serological Reagent |
| Applicant | GENERAL BIOMETRICS, INC. 15222 Avenue Of Science Suite A San Diego, CA 92128 |
| Contact | Bryan L Kiehl |
| Correspondent | Bryan L Kiehl GENERAL BIOMETRICS, INC. 15222 Avenue Of Science Suite A San Diego, CA 92128 |
| Product Code | LSR |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-09 |
| Decision Date | 1991-12-30 |