Submission Details
| 510(k) Number | K112029 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 15, 2011 |
| Decision Date | August 30, 2011 |
| Days to Decision | 46 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 MODEL CALI-05
Aug 2011
Decision
46d
Days
Class 2
Risk
About This 510(k) Submission
K112029 is an FDA 510(k) clearance for the ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II MODEL CALI-05, a Calibrator, Multi-analyte Mixture (Class II — Special Controls, product code JIX), submitted by Elitechgroup (Bothell, US). The FDA issued a Cleared decision on August 30, 2011, 46 days after receiving the submission on July 15, 2011. 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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