The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Quanta Flash Acl Lga, Quanta Flash B2gp1 Iga.
| Device ID | K120817 |
| 510k Number | K120817 |
| Device Name: | QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA |
| Classification | System, Test, Anticardiolipin Immunological |
| Applicant | INOVA DIAGNOSTICS, INC. 9900 OLD GROVE RD. San Diego, CA 92131 -1638 |
| Contact | Rosanna Keivens |
| Correspondent | Rosanna Keivens INOVA DIAGNOSTICS, INC. 9900 OLD GROVE RD. San Diego, CA 92131 -1638 |
| Product Code | MID |
| Subsequent Product Code | JJX |
| Subsequent Product Code | MSV |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-19 |
| Decision Date | 2013-02-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08426951289288 | K120817 | 000 |
| 08426951289257 | K120817 | 000 |
| 08426950596820 | K120817 | 000 |