K053330 is an FDA 510(k) clearance for the ARCHITECT B12 CALIBRATORS. This device is classified as a Calibrator, Secondary (Class II - Special Controls, product code JIT).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on December 16, 2005, 15 days after receiving the submission on December 1, 2005.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1150.
| 510(k) Number | K053330 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 01, 2005 |
| Decision Date | December 16, 2005 |
| Days to Decision | 15 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 |