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FDA 510(k)

ACCU-CHEK ACTIVE TEST SYSTEM

K-Number: K012324 · 2001-12-05

ApplicantRoche Diagnostics Corp.
Decision Date2001-12-05
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACCU-CHEK ACTIVE TEST 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 2001-12-05 under 510(k) number K012324. 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 ACTIVE TEST SYSTEM?

ACCU-CHEK ACTIVE TEST SYSTEM is a medical device that received FDA 510(k) clearance on 2001-12-05. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K012324.

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

ACCU-CHEK ACTIVE TEST SYSTEM received FDA 510(k) clearance on 2001-12-05, under 510(k) number K012324.

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

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

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Other records listing Roche Diagnostics Corp. 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.

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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.

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