K885317 is an FDA 510(k) clearance for the LYME ELISA TEST SYSTEM. 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 March 2, 1989, 62 days after receiving the submission on December 30, 1988.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3830.
| 510(k) Number | K885317 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 1988 |
| Decision Date | March 02, 1989 |
| Days to Decision | 62 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 |