K980312 is an FDA 510(k) clearance for the NOVA LITE ENDOMYSIAL. This device is classified as a Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control (Class II - Special Controls, product code DBL).
Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on April 2, 1998, 65 days after receiving the submission on January 27, 1998.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5660.
| 510(k) Number | K980312 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 27, 1998 |
| Decision Date | April 02, 1998 |
| Days to Decision | 65 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | DBL — Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5660 |