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FDA 510(k)

ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM

K-Number: K131366 · 2013-10-11

ApplicantRoche Diagnostics Operations, Inc.
Decision Date2013-10-11
Product CodeLFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Operations, Inc.. It received FDA 510(k) clearance on 2013-10-11 under 510(k) number K131366. 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 ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM?

ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2013-10-11. The listed applicant is Roche Diagnostics Operations, Inc.. The 510(k) number is K131366.

When did ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM receive FDA 510(k) clearance?

ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM received FDA 510(k) clearance on 2013-10-11, under 510(k) number K131366.

Who is the listed applicant for ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM?

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

What is the FDA product code for ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM?

The FDA product code for ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM is LFR.

Related Clinical Trials

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.

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Other records listing Roche Diagnostics Operations, Inc. 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.

K131029ACCU-CHEK AVIVA PLUS TEST STRIP

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.

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 CorporationK113307GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEMHmd Biomedical, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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