Submission Details
| 510(k) Number | K103376 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 17, 2010 |
| Decision Date | November 18, 2011 |
| Days to Decision | 366 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTEMS ELICAL 2 MODEL CALI-0580, ELITECH CL
Nov 2011
Decision
366d
Days
Class 2
Risk
About This 510(k) Submission
K103376 is an FDA 510(k) clearance for the ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTEMS ELICAL 2 MODEL CALI-0580, ELITECH CL, a Enzymatic Method, Creatinine (Class II — Special Controls, product code JFY), submitted by Seppim S.A.S. (Bothell, US). The FDA issued a Cleared decision on November 18, 2011, 366 days after receiving the submission on November 17, 2010. 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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