Submission Details
| 510(k) Number | K100547 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 25, 2010 |
| Decision Date | May 19, 2011 |
| Days to Decision | 448 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
ELITECH CLINICAL SYSTEMS HBA1C REAGENT, ELITECH CLINCAL SYSTEM HBA1C CALIBRATOR SET, ELITECH CLINICAL
May 2011
Decision
448d
Days
Class 2
Risk
About This 510(k) Submission
K100547 is an FDA 510(k) clearance for the ELITECH CLINICAL SYSTEMS HBA1C REAGENT, ELITECH CLINCAL SYSTEM HBA1C CALIBRATOR SET, ELITECH CLINICAL, a Assay, Glycosylated Hemoglobin (Class II — Special Controls, product code LCP), submitted by Seppim S.A.S. (Bothell, US). The FDA issued a Cleared decision on May 19, 2011, 448 days after receiving the submission on February 25, 2010. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.7470.
Device Classification
| Product Code | LCP — Assay, Glycosylated Hemoglobin |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 864.7470 |
Manufacturer
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