Cleared Traditional

MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227

K082227 · Sebia · Hematology
Mar 2009
Decision
231d
Days
Class 2
Risk

About This 510(k) Submission

K082227 is an FDA 510(k) clearance for the MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227, a Abnormal Hemoglobin Quantitation (Class II — Special Controls, product code GKA), submitted by Sebia (Norcross, US). The FDA issued a Cleared decision on March 26, 2009, 231 days after receiving the submission on August 7, 2008. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7415.

Submission Details

510(k) Number K082227 FDA.gov
FDA Decision Cleared SESE
Date Received August 07, 2008
Decision Date March 26, 2009
Days to Decision 231 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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