K050790 is an FDA 510(k) clearance for the SPOTCHEM II LDH TEST. This device is classified as a Tetrazolium Int Dye-diaphorase, Lactate Dehydrogenase (Class II - Special Controls, product code CFH).
Submitted by Arkray, Inc. (Cortlandt Manor, US). The FDA issued a Cleared decision on June 6, 2005, 70 days after receiving the submission on March 28, 2005.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1440.
| 510(k) Number | K050790 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 28, 2005 |
| Decision Date | June 06, 2005 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CFH - Tetrazolium Int Dye-diaphorase, Lactate Dehydrogenase |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1440 |