K965129 is an FDA 510(k) clearance for the BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM. This device is classified as a Reagent, Borrelia Serological Reagent (Class II - Special Controls, product code LSR).
Submitted by Wampole Laboratories (Cranbury, US). The FDA issued a Cleared decision on March 26, 1997, 93 days after receiving the submission on December 23, 1996.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3830.
| 510(k) Number | K965129 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 1996 |
| Decision Date | March 26, 1997 |
| Days to Decision | 93 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LSR — Reagent, Borrelia Serological Reagent |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3830 |