K780563 is an FDA 510(k) clearance for the SINGLE VIAL LACTATE. 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 April 18, 1978, 11 days after receiving the submission on April 7, 1978.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 862.1440.
| 510(k) Number | K780563 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 07, 1978 |
| Decision Date | April 18, 1978 |
| Days to Decision | 11 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | CFJ — Nad Reduction/nadh Oxidation, Lactate Dehydrogenase |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1440 |