K981328 is an FDA 510(k) clearance for the QUANTA LITE PR3 IGG (SERINE PROTEASE) TEST KIT. This device is classified as a Test System, Antineutrophil Cytoplasmic Antibodies (anca) (Class II - Special Controls, product code MOB).
Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on June 19, 1998, 67 days after receiving the submission on April 13, 1998.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5660.
| 510(k) Number | K981328 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 13, 1998 |
| Decision Date | June 19, 1998 |
| Days to Decision | 67 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | MOB — Test System, Antineutrophil Cytoplasmic Antibodies (anca) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5660 |