K133676 is an FDA 510(k) clearance for the ABX PENTRA MICRO ALB CONTROL L/H. This device is classified as a Multi-analyte Controls, All Kinds (assayed) (Class I - General Controls, product code JJY).
Submitted by HORIBA ABX SAS (Montpellier, FR). The FDA issued a Cleared decision on July 11, 2014, 224 days after receiving the submission on November 29, 2013.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1660.
| 510(k) Number | K133676 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 29, 2013 |
| Decision Date | July 11, 2014 |
| Days to Decision | 224 days |
| Submission Type | Abbreviated |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JJY - Multi-analyte Controls, All Kinds (assayed) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1660 |