K770401 is an FDA 510(k) clearance for the LDH/NADH,LDH/NADH, NAD & NAD DIAPHORASE. This device is classified as a Analyzer, Enzyme, For Clinical Use (Class I - General Controls, product code JJI).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on April 26, 1977, 55 days after receiving the submission on March 2, 1977.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2500.
| 510(k) Number | K770401 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 02, 1977 |
| Decision Date | April 26, 1977 |
| Days to Decision | 55 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JJI — Analyzer, Enzyme, For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2500 |