The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Quanta Flash Ccp3, Quanta Flash Ccp3 Calibrators, And Quanta Flash Ccp3.
| Device ID | K143754 |
| 510k Number | K143754 |
| Device Name: | QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, And QUANTA Flash CCP3 |
| Classification | Antibodies, Anti-cyclic Citrullinated Peptide (ccp) |
| Applicant | INOVA DIAGNOSTICS, INC. 9900 OLD GROVE ROAD San Diego, CA 92131 |
| Contact | Gabriella Lakos |
| Correspondent | Gabriella Lakos INOVA DIAGNOSTICS, INC. 9900 OLD GROVE ROAD 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 | 2014-12-31 |
| Decision Date | 2015-09-21 |
| Summary: | summary |