The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Quanta Lite Ccp Elisa.
| Device ID | K020414 |
| 510k Number | K020414 |
| Device Name: | QUANTA LITE CCP ELISA |
| Classification | Antibodies, Anti-cyclic Citrullinated Peptide (ccp) |
| 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 | NHX |
| CFR Regulation Number | 866.5775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-07 |
| Decision Date | 2002-04-29 |