The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Quanta Lite Lyme Igg Elisa.
| Device ID | K984222 |
| 510k Number | K984222 |
| Device Name: | QUANTA LITE LYME IGG ELISA |
| Classification | Reagent, Borrelia Serological Reagent |
| Applicant | INOVA DIAGNOSTICS, INC. 10180 SCRIPPS RANCH BLVD. San Diego, CA 92131 |
| Contact | Brys C Myers |
| Correspondent | Brys C Myers 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 | 1998-11-25 |
| Decision Date | 1999-04-15 |