K950164 is an FDA 510(k) clearance for the PICCOLO(TM) PRIMARY HEALTH PANEL REAGENT ROTOR. This device is classified as a Enzymatic Esterase--oxidase, Cholesterol (Class I - General Controls, product code CHH).
Submitted by Abaxis, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on April 13, 1995, 86 days after receiving the submission on January 17, 1995.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1175.
| 510(k) Number | K950164 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 17, 1995 |
| Decision Date | April 13, 1995 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | CHH — Enzymatic Esterase--oxidase, Cholesterol |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1175 |