Submission Details
| 510(k) Number | K132399 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 01, 2013 |
| Decision Date | January 03, 2014 |
| Days to Decision | 155 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL II, URINE CONTROL BI-LEVEL
Jan 2014
Decision
155d
Days
Class 2
Risk
About This 510(k) Submission
K132399 is an FDA 510(k) clearance for the ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL II, URINE CONTROL BI-LEVEL, a Enzymatic Method, Creatinine (Class II — Special Controls, product code JFY), submitted by Elitechgroup (Bothell, US). The FDA issued a Cleared decision on January 3, 2014, 155 days after receiving the submission on August 1, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.
Device Classification
| Product Code | JFY — Enzymatic Method, Creatinine |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1225 |
Manufacturer
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