K850373 is an FDA 510(k) clearance for the ABBOTT RF EIA DIAGNOSTIC KIT. This device is classified as a System, Test, Rheumatoid Factor (Class II - Special Controls, product code DHR).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on March 1, 1985, 29 days after receiving the submission on January 31, 1985.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 866.5775.
| 510(k) Number | K850373 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 31, 1985 |
| Decision Date | March 01, 1985 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | DHR — System, Test, Rheumatoid Factor |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5775 |