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FDA 510(k)

CAPI 3 HEMOGLOBIN(E)

K-Number: K180762 · 2018-12-14

ApplicantSebia
Decision Date2018-12-14
Product CodeGKA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CAPI 3 HEMOGLOBIN(E) is a medical device manufactured by Sebia. It received FDA 510(k) clearance on 2018-12-14 under approval number K180762. The device is classified under product code GKA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAPI 3 HEMOGLOBIN(E)?

CAPI 3 HEMOGLOBIN(E) is a medical device that received FDA 510(k) clearance on 2018-12-14. It is manufactured by Sebia. The 510(k) number is K180762.

When was CAPI 3 HEMOGLOBIN(E) approved by the FDA?

CAPI 3 HEMOGLOBIN(E) received FDA 510(k) clearance on 2018-12-14, under approval number K180762.

What company makes CAPI 3 HEMOGLOBIN(E)?

CAPI 3 HEMOGLOBIN(E) is manufactured by Sebia.

What is the FDA product code for CAPI 3 HEMOGLOBIN(E)?

The FDA product code for CAPI 3 HEMOGLOBIN(E) is GKA.

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Related Devices (Code: GKA)

K171664Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview SoftwareBio-Rad Laboratories, Inc. K192931V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo ControlHelena Laboratories, Corp. K222635Premier Resolution SystemTrinity Biotech (Primus Corporation, Dba Trinity Biotech) K232027CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS InstrumentSebia

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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