The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Quanta Flash Scl-70, Quanta Flash Scl-70 Calibrators, Quanta Flash Scl-70 Controls.
| Device ID | K152635 |
| 510k Number | K152635 |
| Device Name: | QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls |
| Classification | Extractable Antinuclear 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 | LLL |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-15 |
| Decision Date | 2016-06-01 |
| Summary: | summary |