Cleared Traditional

CAPILLARYS HEMOGLOBIN, CAPILLARYS FLEX PIERCING SYSTEM

K112550 · Sebia · Hematology
May 2012
Decision
267d
Days
Class 2
Risk

About This 510(k) Submission

K112550 is an FDA 510(k) clearance for the CAPILLARYS HEMOGLOBIN, CAPILLARYS FLEX PIERCING SYSTEM, a Abnormal Hemoglobin Quantitation (Class II — Special Controls, product code GKA), submitted by Sebia (Norcross, US). The FDA issued a Cleared decision on May 25, 2012, 267 days after receiving the submission on September 1, 2011. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7415.

Submission Details

510(k) Number K112550 FDA.gov
FDA Decision Cleared SESE
Date Received September 01, 2011
Decision Date May 25, 2012
Days to Decision 267 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

Product Code GKA — Abnormal Hemoglobin Quantitation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7415

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