FDA 510(k)

MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM

K-Number: K021827 · 2002-07-03

Decision Date2002-07-03

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM 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 2002-07-03 under 510(k) number K021827. 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 MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM?

MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM is a medical device that received FDA 510(k) clearance on 2002-07-03. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K021827.

When did MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM received FDA 510(k) clearance on 2002-07-03, under 510(k) number K021827.

Who is the listed applicant for MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM?

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 MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM?

The FDA product code for MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM is NBW. This falls under the OB/GYN category.

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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.