K092570 is an FDA 510(k) clearance for the ABX PENTRA TPU CAL, MODEL A11A01898. This device is classified as a Calibrator, Secondary (Class II - Special Controls, product code JIT).
Submitted by HORIBA ABX SAS (Montpellier Cedex 4, FR). The FDA issued a Cleared decision on October 16, 2009, 56 days after receiving the submission on August 21, 2009.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1150.
| 510(k) Number | K092570 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 21, 2009 |
| Decision Date | October 16, 2009 |
| Days to Decision | 56 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 |