K820378 is an FDA 510(k) clearance for the LD-L TRIS SYSTEM PACK TEST. This device is classified as a Nad Reduction/nadh Oxidation, Lactate Dehydrogenase (Class II - Special Controls, product code CFJ).
Submitted by Boehringer Mannheim Corp. (Mchenry, US). The FDA issued a Cleared decision on March 8, 1982, 27 days after receiving the submission on February 9, 1982.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1440.
| 510(k) Number | K820378 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 09, 1982 |
| Decision Date | March 08, 1982 |
| Days to Decision | 27 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CFJ — Nad Reduction/nadh Oxidation, Lactate Dehydrogenase |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1440 |