K871246 is an FDA 510(k) clearance for the IFA TEST FOR ANTIBODIES TO BORRELIA BURGDORFERI. This device is classified as a Reagent, Borrelia Serological Reagent (Class II - Special Controls, product code LSR).
Submitted by Zeus Scientific, Inc. (Raritan, US). The FDA issued a Cleared decision on August 25, 1987, 151 days after receiving the submission on March 27, 1987.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3830.
| 510(k) Number | K871246 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 27, 1987 |
| Decision Date | August 25, 1987 |
| Days to Decision | 151 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 |