K961169 is an FDA 510(k) clearance for the RHEUMATOID FACTOR LATEX SLIDE TEST KIT. This device is classified as a System, Test, Rheumatoid Factor (Class II - Special Controls, product code DHR).
Submitted by Randox Laboratories, Ltd. (Crumlin, IE). The FDA issued a Cleared decision on June 26, 1996, 93 days after receiving the submission on March 25, 1996.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5775.
| 510(k) Number | K961169 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 25, 1996 |
| Decision Date | June 26, 1996 |
| Days to Decision | 93 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 |