K894410 is an FDA 510(k) clearance for the IMMUNODOT LYME TEST. This device is classified as a Reagent, Borrelia Serological Reagent (Class II — Special Controls, product code LSR).
Submitted by General Biometrics, Inc. (San Diego, US). The FDA issued a Cleared decision on October 30, 1989, 105 days after receiving the submission on July 17, 1989.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3830.
| 510(k) Number | K894410 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 17, 1989 |
| Decision Date | October 30, 1989 |
| Days to Decision | 105 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | LSR — Reagent, Borrelia Serological Reagent |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.3830 |