K953291 is an FDA 510(k) clearance for the QUANTA LITE ACA SCREEN (HRP). 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 August 29, 1995, 46 days after receiving the submission on July 14, 1995.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5660.
| 510(k) Number | K953291 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 14, 1995 |
| Decision Date | August 29, 1995 |
| Days to Decision | 46 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 |