The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Quanta Flash Sm, Quanta Flash Rnp, Quanta Flash Sm Calibrators, Quanta Flash Rnp Calibrators, Quanta Flash Sm Controls,.
| Device ID | K123593 |
| 510k Number | K123593 |
| Device Name: | QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP CALIBRATORS, QUANTA FLASH SM CONTROLS, |
| Classification | Anti-sm Antibody, Antigen And Control |
| Applicant | INOVA DIAGNOSTICS, INC. 9900 OLD GROVE RD. San Diego, CA 92131 -1638 |
| Contact | Gabriella Lakos |
| Correspondent | Gabriella Lakos INOVA DIAGNOSTICS, INC. 9900 OLD GROVE RD. San Diego, CA 92131 -1638 |
| Product Code | LKP |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| Subsequent Product Code | LKO |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-21 |
| Decision Date | 2013-04-17 |
| Summary: | summary |