K946034 is an FDA 510(k) clearance for the QUANTA LITE(TM) IGG (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 July 18, 1995, 221 days after receiving the submission on December 9, 1994.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5660.
| 510(k) Number | K946034 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 09, 1994 |
| Decision Date | July 18, 1995 |
| Days to Decision | 221 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 |