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FDA 510(k)

ACCU-CHEK ULTRFLEX INFUSION SET

K-Number: K101196 · 2010-08-27

ApplicantRoche Diagnostics Corp.
Decision Date2010-08-27
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ACCU-CHEK ULTRFLEX INFUSION SET is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corp.. It received FDA 510(k) clearance on 2010-08-27 under 510(k) number K101196. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCU-CHEK ULTRFLEX INFUSION SET?

ACCU-CHEK ULTRFLEX INFUSION SET is a medical device that received FDA 510(k) clearance on 2010-08-27. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K101196.

When did ACCU-CHEK ULTRFLEX INFUSION SET receive FDA 510(k) clearance?

ACCU-CHEK ULTRFLEX INFUSION SET received FDA 510(k) clearance on 2010-08-27, under 510(k) number K101196.

Who is the listed applicant for ACCU-CHEK ULTRFLEX INFUSION SET?

The FDA 510(k) record lists Roche Diagnostics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACCU-CHEK ULTRFLEX INFUSION SET?

The FDA product code for ACCU-CHEK ULTRFLEX INFUSION SET is FPA.

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Other records listing Roche Diagnostics Corp. as applicant

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K130138SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEMK101365ELECSYS CA 19-9 CALCHECK 5K100853COBAS 8000 MODULAR SERIES ANALYZERK093664AMPHETAMINES II ASSAYK101075ELECSYS INSULIN CALCHECK 5K093421ELECSYS TESTOSTERONE II IMMUNOASSAY

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Related Devices (Code: FPA)

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.

K254123Ecomed Disposable Administration SetsEcomed Solutions, LLCK261530iiSure Infusion SetDeka Research and DevelopmentK252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)Amsino International, Inc.K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]Np MedicalK250325BD Alaris Pump Infusion SetCarefusion (Bd)

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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