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FDA 510(k)

GLYCOHEMOSURE HBA1C CONTROL

K-Number: K032791 · 2003-10-30

ApplicantQuantimetrix Corp.
Decision Date2003-10-30
Product CodeGGM
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

GLYCOHEMOSURE HBA1C CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Quantimetrix Corp.. It received FDA 510(k) clearance on 2003-10-30 under 510(k) number K032791. The device is classified under product code GGM. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLYCOHEMOSURE HBA1C CONTROL?

GLYCOHEMOSURE HBA1C CONTROL is a medical device that received FDA 510(k) clearance on 2003-10-30. The listed applicant is Quantimetrix Corp.. The 510(k) number is K032791.

When did GLYCOHEMOSURE HBA1C CONTROL receive FDA 510(k) clearance?

GLYCOHEMOSURE HBA1C CONTROL received FDA 510(k) clearance on 2003-10-30, under 510(k) number K032791.

Who is the listed applicant for GLYCOHEMOSURE HBA1C CONTROL?

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

What is the FDA product code for GLYCOHEMOSURE HBA1C CONTROL?

The FDA product code for GLYCOHEMOSURE HBA1C CONTROL is GGM.

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Related Devices (Code: GGM)

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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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