The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Quanta Lite Celiac Dgp Screen.
| Device ID | K062708 |
| 510k Number | K062708 |
| Device Name: | QUANTA LITE CELIAC DGP SCREEN |
| Classification | Antibodies, Gliadin |
| Applicant | INOVA DIAGNOSTICS, INC. 9900 OLD GROVE RD. San Diego, CA 92131 -1638 |
| Contact | Donna L Gustafson |
| Correspondent | Donna L Gustafson INOVA DIAGNOSTICS, INC. 9900 OLD GROVE RD. San Diego, CA 92131 -1638 |
| Product Code | MST |
| CFR Regulation Number | 866.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-11 |
| Decision Date | 2006-12-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08426950593324 | K062708 | 000 |