Submission Details
| 510(k) Number | K100525 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 24, 2010 |
| Decision Date | December 15, 2010 |
| Days to Decision | 294 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2
Dec 2010
Decision
294d
Days
Class 2
Risk
About This 510(k) Submission
K100525 is an FDA 510(k) clearance for the ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2, a Glucose Oxidase, Glucose (Class II — Special Controls, product code CGA), submitted by Seppim S.A.S. (Bothell, US). The FDA issued a Cleared decision on December 15, 2010, 294 days after receiving the submission on February 24, 2010. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.
Device Classification
| Product Code | CGA — Glucose Oxidase, Glucose |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1345 |
Manufacturer
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