Cleared Traditional

CAPI 3 HEMOGLOBIN(E)

K180762 · Sebia · Hematology
Dec 2018
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K180762 is an FDA 510(k) clearance for the CAPI 3 HEMOGLOBIN(E), a Abnormal Hemoglobin Quantitation (Class II — Special Controls, product code GKA), submitted by Sebia (Norcross, US). The FDA issued a Cleared decision on December 14, 2018, 266 days after receiving the submission on March 23, 2018. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7415.

Submission Details

510(k) Number K180762 FDA.gov
FDA Decision Cleared SESE
Date Received March 23, 2018
Decision Date December 14, 2018
Days to Decision 266 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

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

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