K931116 is an FDA 510(k) clearance for the IL TEST(TM) TRIGLYCERIDE. This device is classified as a Colorimetric Method, Triglycerides (Class I - General Controls, product code JGY).
Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on March 28, 1994, 389 days after receiving the submission on March 4, 1993.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.1705.
| 510(k) Number | K931116 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 04, 1993 |
| Decision Date | March 28, 1994 |
| Days to Decision | 389 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | JGY — Colorimetric Method, Triglycerides |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1705 |