K972456 is an FDA 510(k) clearance for the RHEUMACOL RHEUMATOID FACTOR TEST. This device is classified as a System, Test, Rheumatoid Factor (Class II - Special Controls, product code DHR).
Submitted by Immunostics Inc., (Ocean, US). The FDA issued a Cleared decision on November 25, 1997, 147 days after receiving the submission on July 1, 1997.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5775.
| 510(k) Number | K972456 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 1997 |
| Decision Date | November 25, 1997 |
| Days to Decision | 147 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 |