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 |