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FDA 510(k)

CAPI 3 Hb A1c

K-Number: K171537 · 2017-09-12

ApplicantSebia
Decision Date2017-09-12
Product CodePDJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CAPI 3 Hb A1c is the device name listed in this FDA 510(k) record. The listed applicant is Sebia. It received FDA 510(k) clearance on 2017-09-12 under 510(k) number K171537. The device is classified under product code PDJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAPI 3 Hb A1c?

CAPI 3 Hb A1c is a medical device that received FDA 510(k) clearance on 2017-09-12. The listed applicant is Sebia. The 510(k) number is K171537.

When did CAPI 3 Hb A1c receive FDA 510(k) clearance?

CAPI 3 Hb A1c received FDA 510(k) clearance on 2017-09-12, under 510(k) number K171537.

Who is the listed applicant for CAPI 3 Hb A1c?

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 Hb A1c?

The FDA product code for CAPI 3 Hb A1c is PDJ.

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: PDJ)

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.

K252749Medconn 8K Glycated Hemoglobin Test SystemShanghai Medconn Medical Technology Co., Ltd.K250073Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01Tosoh Bioscience, Inc.K242911Medconn Glycated Hemoglobin Test systemShanghai Medconn Medical Technology Co., Ltd.K220999Hipro Glycosylated Hemoglobin (HbA1c) Test SystemShijiazhuang Hipro Biotechnology Co., Ltd.K200904Tosoh Automated Glycohemoglobin Analyzer HLC-723G8Tosoh Bioscience, Inc.K200256ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) AssaySiemens Healthcare Diagnostics, 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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