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FDA 510(k)

ACCU-CHEK AVIVA PLUS TEST STRIP

K-Number: K131029 · 2013-08-09

ApplicantRoche Diagnostics Operations, Inc.
Decision Date2013-08-09
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACCU-CHEK AVIVA PLUS TEST STRIP 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 2013-08-09 under 510(k) number K131029. The device is classified under product code NBW. It was reviewed by the CH advisory panel. Product code NBW falls under the category of OB/GYN, which includes obstetric and gynecological diagnostic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCU-CHEK AVIVA PLUS TEST STRIP?

ACCU-CHEK AVIVA PLUS TEST STRIP is a medical device that received FDA 510(k) clearance on 2013-08-09. The listed applicant is Roche Diagnostics Operations, Inc.. The 510(k) number is K131029.

When did ACCU-CHEK AVIVA PLUS TEST STRIP receive FDA 510(k) clearance?

ACCU-CHEK AVIVA PLUS TEST STRIP received FDA 510(k) clearance on 2013-08-09, under 510(k) number K131029.

Who is the listed applicant for ACCU-CHEK AVIVA PLUS TEST STRIP?

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 PLUS TEST STRIP?

The FDA product code for ACCU-CHEK AVIVA PLUS TEST STRIP is NBW. This falls under the OB/GYN category.

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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.

K131366ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM

Related Devices (Code: NBW)

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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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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