Submission Details
| 510(k) Number | K141265 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 15, 2014 |
| Decision Date | July 18, 2014 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT
Jul 2014
Decision
64d
Days
Class 2
Risk
About This 510(k) Submission
K141265 is an FDA 510(k) clearance for the ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT, a U.v. Method, Cpk Isoenzymes (Class II — Special Controls, product code JHW), submitted by Elitechgroup (Bothell, US). The FDA issued a Cleared decision on July 18, 2014, 64 days after receiving the submission on May 15, 2014. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.
Device Classification
| Product Code | JHW — U.v. Method, Cpk Isoenzymes |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1215 |
Manufacturer
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