K042651 is an FDA 510(k) clearance for the FREE T3 CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS. This device is classified as a Calibrator, Secondary (Class II - Special Controls, product code JIT).
Submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on October 5, 2004, 7 days after receiving the submission on September 28, 2004.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.1150.
| 510(k) Number | K042651 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 2004 |
| Decision Date | October 05, 2004 |
| Days to Decision | 7 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | JIT — Calibrator, Secondary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1150 |