K852556 is an FDA 510(k) clearance for the TDX REA TRIGLYCERIDES. This device is classified as a Fluorometric Method, Triglycerides (Class I - General Controls, product code JGW).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on July 22, 1985, 35 days after receiving the submission on June 17, 1985.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1705.
| 510(k) Number | K852556 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 17, 1985 |
| Decision Date | July 22, 1985 |
| Days to Decision | 35 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 |