K780173 is an FDA 510(k) clearance for the LYPOPROTEIN CHOLESTEROL TEST KIT. This device is classified as a Colorimetric Method, Lipoproteins (Class I - General Controls, product code JHM).
Submitted by Environmental Chemical Specialties (Mchenry, US). The FDA issued a Cleared decision on May 3, 1978, 90 days after receiving the submission on February 2, 1978.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1475.
| 510(k) Number | K780173 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 02, 1978 |
| Decision Date | May 03, 1978 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JHM — Colorimetric Method, Lipoproteins |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1475 |