K080166 is an FDA 510(k) clearance for the ACCESS ESTRADIOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33545. 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 March 19, 2008, 56 days after receiving the submission on January 23, 2008.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1150.
| 510(k) Number | K080166 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 23, 2008 |
| Decision Date | March 19, 2008 |
| Days to Decision | 56 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JIT — Calibrator, Secondary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1150 |