Cleared Traditional

CAPILLARYS HEMOGLOBIN HBA1C CAPILLARYS 2 FLEX PIERCING CAPILLARYS HBA1C CONTROLS CAPILLARYS HBA1C C

K122101 · Sebia · Chemistry
Dec 2012
Decision
143d
Days
Class 2
Risk

About This 510(k) Submission

K122101 is an FDA 510(k) clearance for the CAPILLARYS HEMOGLOBIN HBA1C CAPILLARYS 2 FLEX PIERCING CAPILLARYS HBA1C CONTROLS CAPILLARYS HBA1C C, a Assay, Glycosylated Hemoglobin (Class II — Special Controls, product code LCP), submitted by Sebia (Norcross, US). The FDA issued a Cleared decision on December 6, 2012, 143 days after receiving the submission on July 16, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.7470.

Submission Details

510(k) Number K122101 FDA.gov
FDA Decision Cleared SESE
Date Received July 16, 2012
Decision Date December 06, 2012
Days to Decision 143 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code LCP — Assay, Glycosylated Hemoglobin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7470

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