The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Quanta Lite Gpa (gastric Parietal Cell Antibody) Elisa.
| Device ID | K010558 |
| 510k Number | K010558 |
| Device Name: | QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA |
| Classification | Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control |
| Applicant | INOVA DIAGNOSTICS, INC. 10180 SCRIPPS RANCH BLVD. San Diego, CA 92131 |
| Contact | Brys C Myers |
| Correspondent | Brys C Myers INOVA DIAGNOSTICS, INC. 10180 SCRIPPS RANCH BLVD. San Diego, CA 92131 |
| Product Code | MLE |
| CFR Regulation Number | 866.5110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-26 |
| Decision Date | 2001-04-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08426950448310 | K010558 | 000 |