The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Quanta Flash Dgp Iga, Quanta Flash Dgp Igg, Quanta Flash Dgp Iga Calibrators, Quanta Flash Dgp Igg Calibrators.
| Device ID | K113863 |
| 510k Number | K113863 |
| Device Name: | QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QUANTA FLASH DGP IGG CALIBRATORS |
| Classification | Antibodies, Gliadin |
| 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 | MST |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 866.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-30 |
| Decision Date | 2012-09-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08426950627753 | K113863 | 000 |
| 08426950544173 | K113863 | 000 |
| 08426950544166 | K113863 | 000 |