K900206 is an FDA 510(k) clearance for the LYME DISEASE IGM ELISA. This device is classified as a Reagent, Borrelia Serological Reagent (Class II - Special Controls, product code LSR).
Submitted by Hillcrest Biologicals (Cypress, US). The FDA issued a Cleared decision on June 28, 1991, 528 days after receiving the submission on January 16, 1990.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3830.
| 510(k) Number | K900206 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 16, 1990 |
| Decision Date | June 28, 1991 |
| Days to Decision | 528 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 |