The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Quanta Lite Lyme B. Burgdorferi Igg/igm Elisa Kit.
| Device ID | K994004 |
| 510k Number | K994004 |
| Device Name: | QUANTA LITE LYME B. BURGDORFERI IGG/IGM ELISA KIT |
| Classification | Reagent, Borrelia Serological Reagent |
| Applicant | INOVA DIAGNOSTICS, INC. 10180 SCRIPPS RANCH BLVD. San Diego, CA 92131 |
| Contact | Gary L Norman |
| Correspondent | Gary L Norman INOVA DIAGNOSTICS, INC. 10180 SCRIPPS RANCH BLVD. San Diego, CA 92131 |
| Product Code | LSR |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-24 |
| Decision Date | 2000-01-27 |