K050077 is an FDA 510(k) clearance for the SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTS. This device is classified as a Cresolphthalein Complexone, Calcium (Class II - Special Controls, product code CIC).
Submitted by Arkray, Inc. (Cortlandt Manor, US). The FDA issued a Cleared decision on February 15, 2005, 34 days after receiving the submission on January 12, 2005.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1145.
| 510(k) Number | K050077 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 12, 2005 |
| Decision Date | February 15, 2005 |
| Days to Decision | 34 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | CIC - Cresolphthalein Complexone, Calcium |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1145 |