K780439 is an FDA 510(k) clearance for the PRECIMAT GLYCEROL. This device is classified as a Fluorometric Method, Triglycerides (Class I - General Controls, product code JGW).
Submitted by Boehringer Mannheim Corp. (Mchenry, US). The FDA issued a Cleared decision on April 18, 1978, 29 days after receiving the submission on March 20, 1978.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1705.
| 510(k) Number | K780439 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 20, 1978 |
| Decision Date | April 18, 1978 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JGW — Fluorometric Method, Triglycerides |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1705 |