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FDA 510(k)

CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM

K-Number: K111268 · 2012-03-06

ApplicantBayer Healthcare
Decision Date2012-03-06
Product CodeLFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Healthcare. It received FDA 510(k) clearance on 2012-03-06 under 510(k) number K111268. The device is classified under product code LFR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM?

CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2012-03-06. The listed applicant is Bayer Healthcare. The 510(k) number is K111268.

When did CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM receive FDA 510(k) clearance?

CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM received FDA 510(k) clearance on 2012-03-06, under 510(k) number K111268.

Who is the listed applicant for CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM?

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

What is the FDA product code for CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM?

The FDA product code for CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM is LFR.

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Other records listing Bayer Healthcare 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.

K122370CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITORK121087CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEMK110894CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METERK091820CONTOUR USB BLOOD GLUCOSE METER, GLUCOSE TEST STRIPS; GLUCOFACTS DELUX DIABETES MANAGEMENT SYSTEMK062058ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STRIP, MODEL 7080K060470ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; ASCENSIA MICROFILL REAGENT STRIP, MODEL 7080

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Related Devices (Code: LFR)

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.

K131366ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEMRoche Diagnostics Operations, Inc.K122688NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITORNova Biomedical CorporationK121433GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMSHmd Biomedical, Inc.K122435NOVA ONE BLOOD GLUCOSE MONITORNova Biomedical CorporationK113314PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEMHmd Biomedical, Inc.K121224GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEMTaidoc Technology Corporation

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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