K002905 is an FDA 510(k) clearance for the ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER. This device is classified as a System, Test, Thyroglobulin (Class II - Special Controls, product code MSW).
Submitted by Beckman Coulter, Inc. (San Diego, US). The FDA issued a Cleared decision on October 19, 2000, 31 days after receiving the submission on September 18, 2000.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.6010.
| 510(k) Number | K002905 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 18, 2000 |
| Decision Date | October 19, 2000 |
| Days to Decision | 31 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | MSW — System, Test, Thyroglobulin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.6010 |