K132400 is an FDA 510(k) clearance for the LP(A) CALIBRATORS, AND LP(A) CONTROLS. This device is classified as a Calibrator, Secondary (Class II - Special Controls, product code JIT).
Submitted by Biokit, S.A. (Llissa D'Amunt, Barcelona, ES). The FDA issued a Cleared decision on December 19, 2013, 140 days after receiving the submission on August 1, 2013.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1150.
| 510(k) Number | K132400 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 01, 2013 |
| Decision Date | December 19, 2013 |
| Days to Decision | 140 days |
| Submission Type | Abbreviated |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JIT — Calibrator, Secondary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1150 |