Cleared Traditional

CAPILLARYS NEONAT HB (PN 2006)

K091283 · Sebia · Hematology
Feb 2010
Decision
297d
Days
Class 2
Risk

About This 510(k) Submission

K091283 is an FDA 510(k) clearance for the CAPILLARYS NEONAT HB (PN 2006), a Abnormal Hemoglobin Quantitation (Class II — Special Controls, product code GKA), submitted by Sebia (Norcross, US). The FDA issued a Cleared decision on February 22, 2010, 297 days after receiving the submission on May 1, 2009. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7415.

Submission Details

510(k) Number K091283 FDA.gov
FDA Decision Cleared SESE
Date Received May 01, 2009
Decision Date February 22, 2010
Days to Decision 297 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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