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FDA 510(k)

MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227

K-Number: K082227 · 2009-03-26

ApplicantSebia
Decision Date2009-03-26
Product CodeGKA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227 is the device name listed in this FDA 510(k) record. The listed applicant is Sebia. It received FDA 510(k) clearance on 2009-03-26 under 510(k) number K082227. 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 MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227?

MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227 is a medical device that received FDA 510(k) clearance on 2009-03-26. The listed applicant is Sebia. The 510(k) number is K082227.

When did MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227 receive FDA 510(k) clearance?

MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227 received FDA 510(k) clearance on 2009-03-26, under 510(k) number K082227.

Who is the listed applicant for MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227?

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 MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227?

The FDA product code for MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227 is GKA.

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Other records listing Sebia as applicant

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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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