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FDA 510(k)

SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2

K-Number: K112491 · 2012-05-24

ApplicantSebia
Decision Date2012-05-24
Product CodeGKA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2 is the device name listed in this FDA 510(k) record. The listed applicant is Sebia. It received FDA 510(k) clearance on 2012-05-24 under 510(k) number K112491. 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 SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2?

SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2 is a medical device that received FDA 510(k) clearance on 2012-05-24. The listed applicant is Sebia. The 510(k) number is K112491.

When did SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2 receive FDA 510(k) clearance?

SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2 received FDA 510(k) clearance on 2012-05-24, under 510(k) number K112491.

Who is the listed applicant for SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2?

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 SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2?

The FDA product code for SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2 is GKA.

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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

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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.K180762CAPI 3 HEMOGLOBIN(E)SebiaK171664Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview SoftwareBio-Rad Laboratories, Inc.K112550CAPILLARYS HEMOGLOBIN, CAPILLARYS FLEX PIERCING SYSTEMSebia

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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