K990035 is an FDA 510(k) clearance for the RF. This device is classified as a System, Test, Rheumatoid Factor (Class II - Special Controls, product code DHR).
Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on March 8, 1999, 61 days after receiving the submission on January 6, 1999.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5775.
| 510(k) Number | K990035 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 06, 1999 |
| Decision Date | March 08, 1999 |
| Days to Decision | 61 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | DHR — System, Test, Rheumatoid Factor |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5775 |