The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Quanta Flash M2 (mit3), Quanta Flash M2 (mit3) Calibrators, Quanta Flash M2 (mit3) Controls.
| Device ID | K163525 |
| 510k Number | K163525 |
| Device Name: | QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls |
| Classification | Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control |
| Applicant | Inova Diagnostics, Inc. 9900 Old Grove Road San Diego, CA 92131 -1638 |
| Contact | Peter Martis |
| Correspondent | Roger Albesa Inova Diagnostics, Inc. 9900 Old Grove Road San Diego, CA 92131 -1638 |
| Product Code | DBM |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 866.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-15 |
| Decision Date | 2017-09-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08426950730101 | K163525 | 000 |