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FDA 510(k)

ACCU-CHEK SMART PIX

K-Number: K062395 · 2007-05-09

ApplicantRoche Diagnostics Corp.
Decision Date2007-05-09
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACCU-CHEK SMART PIX 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 2007-05-09 under 510(k) number K062395. 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 SMART PIX?

ACCU-CHEK SMART PIX is a medical device that received FDA 510(k) clearance on 2007-05-09. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K062395.

When did ACCU-CHEK SMART PIX receive FDA 510(k) clearance?

ACCU-CHEK SMART PIX received FDA 510(k) clearance on 2007-05-09, under 510(k) number K062395.

Who is the listed applicant for ACCU-CHEK SMART PIX?

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 SMART PIX?

The FDA product code for ACCU-CHEK SMART PIX is NBW. This falls under the OB/GYN category.

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Other records listing Roche Diagnostics Corp. as applicant

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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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