K894578 is an FDA 510(k) clearance for the IQ LDH. This device is classified as a Tetrazolium Int Dye-diaphorase, Lactate Dehydrogenase (Class II - Special Controls, product code CFH).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on October 17, 1989, 85 days after receiving the submission on July 24, 1989.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.1440.
| 510(k) Number | K894578 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 24, 1989 |
| Decision Date | October 17, 1989 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | CFH — Tetrazolium Int Dye-diaphorase, Lactate Dehydrogenase |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1440 |