Submission Details
| 510(k) Number | K151113 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 27, 2015 |
| Decision Date | July 22, 2015 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
ELITech Clinical Systems CALCIUM ARSENAZO
Jul 2015
Decision
86d
Days
Class 2
Risk
About This 510(k) Submission
K151113 is an FDA 510(k) clearance for the ELITech Clinical Systems CALCIUM ARSENAZO, a Azo Dye, Calcium (Class II — Special Controls, product code CJY), submitted by Elitechgroup (Sees, FR). The FDA issued a Cleared decision on July 22, 2015, 86 days after receiving the submission on April 27, 2015. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1145.
Device Classification
| Product Code | CJY — Azo Dye, Calcium |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1145 |
Manufacturer
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