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FDA 510(k)

VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM

K-Number: K972609 · 1997-08-06

ApplicantBio-Rad
Decision Date1997-08-06
Product CodeLCQ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1997-08-06 under 510(k) number K972609. The device is classified under product code LCQ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM?

VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM is a medical device that received FDA 510(k) clearance on 1997-08-06. The listed applicant is Bio-Rad. The 510(k) number is K972609.

When did VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM receive FDA 510(k) clearance?

VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM received FDA 510(k) clearance on 1997-08-06, under 510(k) number K972609.

Who is the listed applicant for VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM?

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

What is the FDA product code for VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM?

The FDA product code for VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM is LCQ.

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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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