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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 the device name listed in this FDA 510(k) record. The listed applicant is Sebia. It received FDA 510(k) clearance on 2018-12-14 under 510(k) 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. The listed applicant is Sebia. The 510(k) number is K180762.

When did CAPI 3 HEMOGLOBIN(E) receive FDA 510(k) clearance?

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

Who is the listed applicant for CAPI 3 HEMOGLOBIN(E)?

The FDA 510(k) record lists Sebia as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Sebia as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232027CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS InstrumentK231601FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2K210623FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2K203184HYDRASHIFT 2/4 isatuximabK192095CAPI 3 Immunotyping, Capillarys 3 TeraK190851HYDRASHIFT 2/4 daratumumab

View all 12 devices →

Related Devices (Code: GKA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232027CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS InstrumentSebiaK222635Premier Resolution SystemTrinity Biotech (Primus Corporation, Dba Trinity Biotech)K192931V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo ControlHelena Laboratories, Corp.K171664Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview SoftwareBio-Rad Laboratories, Inc.

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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