K050652 is an FDA 510(k) clearance for the SPOTCHEM II CREATININE, AMYLASE & ALP TESTS. This device is classified as a Alkaline Picrate, Colorimetry, Creatinine (Class II - Special Controls, product code CGX).
Submitted by Arkray, Inc. (Cortlandt Manor, US). The FDA issued a Cleared decision on April 6, 2005, 23 days after receiving the submission on March 14, 2005.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1225.
| 510(k) Number | K050652 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 14, 2005 |
| Decision Date | April 06, 2005 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | CGX - Alkaline Picrate, Colorimetry, Creatinine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1225 |