K914033 is an FDA 510(k) clearance for the CHOLESTECH LIPID MONITOR SYST, TRIGLYCERIDES TEST. This device is classified as a Colorimetric Method, Triglycerides (Class I - General Controls, product code JGY).
Submitted by Cholestech Corp. (Hayward, US). The FDA issued a Cleared decision on September 27, 1991, 17 days after receiving the submission on September 10, 1991.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1705.
| 510(k) Number | K914033 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 10, 1991 |
| Decision Date | September 27, 1991 |
| Days to Decision | 17 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | JGY — Colorimetric Method, Triglycerides |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1705 |