K922351 is an FDA 510(k) clearance for the QUANTA LITE(TM) IGA ACA. This device is classified as a System, Test, Anticardiolipin Immunological (Class II - Special Controls, product code MID).
Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on September 29, 1992, 133 days after receiving the submission on May 19, 1992.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5660.
| 510(k) Number | K922351 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 19, 1992 |
| Decision Date | September 29, 1992 |
| Days to Decision | 133 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | MID — System, Test, Anticardiolipin Immunological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5660 |