K040332 is an FDA 510(k) clearance for the POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER. This device is classified as a Analyzer, Chemistry, Micro, For Clinical Use (Class I - General Controls, product code JJF).
Submitted by Arkray, Inc. (Cortlandt Manor, US). The FDA issued a Cleared decision on June 16, 2004, 127 days after receiving the submission on February 10, 2004.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2170.
| 510(k) Number | K040332 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 10, 2004 |
| Decision Date | June 16, 2004 |
| Days to Decision | 127 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | JJF - Analyzer, Chemistry, Micro, For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2170 |