Submission Details
| 510(k) Number | K122083 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 16, 2012 |
| Decision Date | August 22, 2012 |
| Days to Decision | 37 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
ELITECH CLINICAL SYSTEMS CK NAC SL
Aug 2012
Decision
37d
Days
Class 2
Risk
About This 510(k) Submission
K122083 is an FDA 510(k) clearance for the ELITECH CLINICAL SYSTEMS CK NAC SL, 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 August 22, 2012, 37 days after receiving the submission on July 16, 2012. 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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