K032713 is an FDA 510(k) clearance for the BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGG. This device is classified as a Reagent, Borrelia Serological Reagent (Class II — Special Controls, product code LSR).
Submitted by Boston Biomedica, Inc. (West Bridgewater, US). The FDA issued a Cleared decision on November 24, 2003, 83 days after receiving the submission on September 2, 2003.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3830.
| 510(k) Number | K032713 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 02, 2003 |
| Decision Date | November 24, 2003 |
| Days to Decision | 83 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 |