The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Quanta Flash Pr3, Quanta Flash Mpo, Quanta Flash Gbm.
| Device ID | K112545 |
| 510k Number | K112545 |
| Device Name: | QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM |
| Classification | Test System, Antineutrophil Cytoplasmic Antibodies (anca) |
| Applicant | INOVA DIAGNOSTICS, INC. 9900 OLD GROVE RD. San Diego, CA 92131 -1638 |
| Contact | Michael Mahler |
| Correspondent | Michael Mahler INOVA DIAGNOSTICS, INC. 9900 OLD GROVE RD. San Diego, CA 92131 -1638 |
| Product Code | MOB |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJX |
| Subsequent Product Code | MVJ |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-01 |
| Decision Date | 2012-07-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08426950627685 | K112545 | 000 |