K120662 is an FDA 510(k) clearance for the PICCOLO HDL-CAPILLARY TEST SYSTEM. This device is classified as a Colorimetric Method, Lipoproteins (Class I - General Controls, product code JHM).
Submitted by Abaxis, Inc. (Union City, US). The FDA issued a Cleared decision on April 24, 2012, 50 days after receiving the submission on March 5, 2012.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1475.
| 510(k) Number | K120662 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 05, 2012 |
| Decision Date | April 24, 2012 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JHM — Colorimetric Method, Lipoproteins |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1475 |