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FDA 510(k)

CAPILLARYS NEONAT HB (PN 2006)

K-Number: K091283 · 2010-02-22

ApplicantSebia
Decision Date2010-02-22
Product CodeGKA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CAPILLARYS NEONAT HB (PN 2006) is the device name listed in this FDA 510(k) record. The listed applicant is Sebia. It received FDA 510(k) clearance on 2010-02-22 under 510(k) number K091283. 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 CAPILLARYS NEONAT HB (PN 2006)?

CAPILLARYS NEONAT HB (PN 2006) is a medical device that received FDA 510(k) clearance on 2010-02-22. The listed applicant is Sebia. The 510(k) number is K091283.

When did CAPILLARYS NEONAT HB (PN 2006) receive FDA 510(k) clearance?

CAPILLARYS NEONAT HB (PN 2006) received FDA 510(k) clearance on 2010-02-22, under 510(k) number K091283.

Who is the listed applicant for CAPILLARYS NEONAT HB (PN 2006)?

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 CAPILLARYS NEONAT HB (PN 2006)?

The FDA product code for CAPILLARYS NEONAT HB (PN 2006) 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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