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FDA 510(k)

CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2)

K-Number: K162281 · 2017-02-17

ApplicantSebia
Decision Date2017-02-17
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2) is a medical device manufactured by Sebia. It received FDA 510(k) clearance on 2017-02-17 under approval number K162281. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2)?

CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2) is a medical device that received FDA 510(k) clearance on 2017-02-17. It is manufactured by Sebia. The 510(k) number is K162281.

When was CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2) approved by the FDA?

CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2) received FDA 510(k) clearance on 2017-02-17, under approval number K162281.

What company makes CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2)?

CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2) is manufactured by Sebia.

What is the FDA product code for CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2)?

The FDA product code for CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2) is LCP.

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Other Devices by Sebia

K161928CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL K171537CAPI 3 Hb A1c K180762CAPI 3 HEMOGLOBIN(E) K171861CAPILLARYS Hb A1c K172195HYDRASHIFT 2/4 daratumumab, daratumumab Control K192095CAPI 3 Immunotyping, Capillarys 3 Tera

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Related Devices (Code: LCP)

K160762Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control SetDiazyme Laboratories K142664URight Hemoglobin A1c system, FORA A1c SystemTaidoc Technology Corporation K171650Alere Afinion HbA1c and ACR on Afinion 2 analyzerAbbott Rapid Diagnostics K170147Lucica Glycated Albumin-LAsahi Kasei Pharma Corporation K163633cobas HbA1c Test, cobas b 101 systemRoche Diagnostics Operations K161533A1C EZ Glycohemoglobin Analysis SystemBiohermes Co., Ltd.

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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