Submission Details
| 510(k) Number | K113269 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 04, 2011 |
| Decision Date | December 29, 2011 |
| Days to Decision | 55 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
ELITTECH CLINICAL SYSTEMS ALP IFCC SL
Dec 2011
Decision
55d
Days
Class 2
Risk
About This 510(k) Submission
K113269 is an FDA 510(k) clearance for the ELITTECH CLINICAL SYSTEMS ALP IFCC SL, a Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (Class II — Special Controls, product code CJE), submitted by Elitechgroup (Bothell, US). The FDA issued a Cleared decision on December 29, 2011, 55 days after receiving the submission on November 4, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1050.
Device Classification
| Product Code | CJE — Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1050 |
Manufacturer
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