The following data is part of a premarket notification filed by General Biometrics, Inc. with the FDA for Immunowell Borrelia (lyme)test.
| Device ID | K911590 |
| 510k Number | K911590 |
| Device Name: | IMMUNOWELL BORRELIA (LYME)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 | 1991-12-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613745039053 | K911590 | 000 |
| 00847865011259 | K911590 | 000 |
| 00847865011266 | K911590 | 000 |
| 00847865011273 | K911590 | 000 |
| 00847865011280 | K911590 | 000 |
| 00847865011457 | K911590 | 000 |
| 00847865011464 | K911590 | 000 |
| 00847865011471 | K911590 | 000 |
| 00847865011488 | K911590 | 000 |
| 00847865011495 | K911590 | 000 |
| 00613745031101 | K911590 | 000 |
| 00847865001274 | K911590 | 000 |