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FDA 510(k)

CAPILLARYS Hb A1c

K-Number: K171861 · 2018-02-07

ApplicantSebia
Decision Date2018-02-07
Product CodePDJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CAPILLARYS 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 2018-02-07 under 510(k) number K171861. 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 CAPILLARYS Hb A1c?

CAPILLARYS Hb A1c is a medical device that received FDA 510(k) clearance on 2018-02-07. The listed applicant is Sebia. The 510(k) number is K171861.

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

CAPILLARYS Hb A1c received FDA 510(k) clearance on 2018-02-07, under 510(k) number K171861.

Who is the listed applicant for CAPILLARYS 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 CAPILLARYS Hb A1c?

The FDA product code for CAPILLARYS 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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