Cleared Traditional

CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument

K232027 · Sebia · Hematology
Apr 2024
Decision
272d
Days
Class 2
Risk

About This 510(k) Submission

K232027 is an FDA 510(k) clearance for the CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument, a Abnormal Hemoglobin Quantitation (Class II — Special Controls, product code GKA), submitted by Sebia (Norcross, US). The FDA issued a Cleared decision on April 4, 2024, 272 days after receiving the submission on July 7, 2023. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7415.

Submission Details

510(k) Number K232027 FDA.gov
FDA Decision Cleared SESE
Date Received July 07, 2023
Decision Date April 04, 2024
Days to Decision 272 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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