K961277 is an FDA 510(k) clearance for the RF IGM ELISA TEST SYSTEM. This device is classified as a System, Test, Rheumatoid Factor (Class II - Special Controls, product code DHR).
Submitted by Zeus Scientific, Inc. (Raritan, US). The FDA issued a Cleared decision on May 8, 1996, 35 days after receiving the submission on April 3, 1996.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5775.
| 510(k) Number | K961277 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 03, 1996 |
| Decision Date | May 08, 1996 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | DHR — System, Test, Rheumatoid Factor |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5775 |