Submission Details
| 510(k) Number | K151552 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 09, 2015 |
| Decision Date | July 08, 2015 |
| Days to Decision | 29 days |
| Submission Type | Abbreviated |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Abbreviated
ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II
Jul 2015
Decision
29d
Days
Class 2
Risk
About This 510(k) Submission
K151552 is an FDA 510(k) clearance for the ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II, a Calibrator, Multi-analyte Mixture (Class II — Special Controls, product code JIX), submitted by Elitechgroup (Sees, FR). The FDA issued a Cleared decision on July 8, 2015, 29 days after receiving the submission on June 9, 2015. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.
Device Classification
| Product Code | JIX — Calibrator, Multi-analyte Mixture |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1150 |
Manufacturer
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