K811553 is an FDA 510(k) clearance for the REAGENT SET TRIGLYCERIDES. This device is classified as a Lipase-esterase, Enzymatic, Photometric, Lipase (Class I - General Controls, product code CHI).
Submitted by Boehringer Mannheim Corp. (Walker, US). The FDA issued a Cleared decision on June 18, 1981, 16 days after receiving the submission on June 2, 1981.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1465.
| 510(k) Number | K811553 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 02, 1981 |
| Decision Date | June 18, 1981 |
| Days to Decision | 16 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CHI — Lipase-esterase, Enzymatic, Photometric, Lipase |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1465 |