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FDA 510(k)

GLUCOSE HK NEW FORMULATION TEST SYSTEM

K-Number: K062239 · 2006-09-11

ApplicantRoche Diagnostics Corp.
Decision Date2006-09-11
Product CodeCFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOSE HK NEW FORMULATION 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 2006-09-11 under 510(k) number K062239. The device is classified under product code CFR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLUCOSE HK NEW FORMULATION TEST SYSTEM?

GLUCOSE HK NEW FORMULATION TEST SYSTEM is a medical device that received FDA 510(k) clearance on 2006-09-11. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K062239.

When did GLUCOSE HK NEW FORMULATION TEST SYSTEM receive FDA 510(k) clearance?

GLUCOSE HK NEW FORMULATION TEST SYSTEM received FDA 510(k) clearance on 2006-09-11, under 510(k) number K062239.

Who is the listed applicant for GLUCOSE HK NEW FORMULATION 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 GLUCOSE HK NEW FORMULATION TEST SYSTEM?

The FDA product code for GLUCOSE HK NEW FORMULATION TEST SYSTEM is CFR.

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Related Devices (Code: CFR)

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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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