K861419 is an FDA 510(k) clearance for the HI CHEM DIAGNOSTICS LDL REAGENT CARTRIDGE. This device is classified as a Nad Reduction/nadh Oxidation, Lactate Dehydrogenase (Class II - Special Controls, product code CFJ).
Submitted by Hi Chem, Inc. (Brea, US). The FDA issued a Cleared decision on April 28, 1986, 13 days after receiving the submission on April 15, 1986.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1440.
| 510(k) Number | K861419 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 15, 1986 |
| Decision Date | April 28, 1986 |
| Days to Decision | 13 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 |