FDA 510(k)

ACCU-CHEK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM

K-Number: K081389 · 2008-07-15

Decision Date2008-07-15

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

ACCU-CHEK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2008-07-15 under 510(k) number K081389. 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 COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM?

ACCU-CHEK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2008-07-15. The listed applicant is Roche Diagnostics. The 510(k) number is K081389.

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

ACCU-CHEK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM received FDA 510(k) clearance on 2008-07-15, under 510(k) number K081389.

Who is the listed applicant for ACCU-CHEK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM?

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

What is the FDA product code for ACCU-CHEK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM?

The FDA product code for ACCU-CHEK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM is NBW. This falls under the OB/GYN category.

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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.