K930485 is an FDA 510(k) clearance for the QUANTA LITE(TM) THYROID M ELISA. This device is classified as a System, Test, Thyroid Autoantibody (Class II - Special Controls, product code JZO).
Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on March 16, 1993, 46 days after receiving the submission on January 29, 1993.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5870.
| 510(k) Number | K930485 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 29, 1993 |
| Decision Date | March 16, 1993 |
| Days to Decision | 46 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | JZO — System, Test, Thyroid Autoantibody |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5870 |