K994004 is an FDA 510(k) clearance for the QUANTA LITE LYME B. BURGDORFERI IGG/IGM ELISA KIT. This device is classified as a Reagent, Borrelia Serological Reagent (Class II - Special Controls, product code LSR).
Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on January 27, 2000, 64 days after receiving the submission on November 24, 1999.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3830.
| 510(k) Number | K994004 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 24, 1999 |
| Decision Date | January 27, 2000 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | LSR — Reagent, Borrelia Serological Reagent |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3830 |