The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Quanta Flash Calprotectin Reagents, Quanta Flash Calprotectin Calibrators, Quanta Flash Calprotectin Controls, Quanta Flash Calprotectin Extraction Buffer.
| Device ID | K170993 |
| 510k Number | K170993 |
| Device Name: | QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer |
| Classification | Calprotectin, Fecal |
| Applicant | Inova Diagnostics, Inc. 9900 Old Grove Road San Diego, CA 92131 -1638 |
| Contact | Roger Albesa |
| Correspondent | Roger Albesa Inova Diagnostics, Inc. 9900 Old Grove Road San Diego, CA 92131 -1638 |
| Product Code | NXO |
| CFR Regulation Number | 866.5180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-03 |
| Decision Date | 2017-12-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08426950928782 | K170993 | 000 |
| 08426950914693 | K170993 | 000 |
| 08426950907220 | K170993 | 000 |
| 08426950907206 | K170993 | 000 |