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FDA 510(k)

CRITERION, HEMOCUE B-HEMOGLOBIN CONTROL

K-Number: K921681 · 1992-11-17

ApplicantIsolab, Inc.
Decision Date1992-11-17
Product CodeGGM
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CRITERION, HEMOCUE B-HEMOGLOBIN CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Isolab, Inc.. It received FDA 510(k) clearance on 1992-11-17 under 510(k) number K921681. 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 CRITERION, HEMOCUE B-HEMOGLOBIN CONTROL?

CRITERION, HEMOCUE B-HEMOGLOBIN CONTROL is a medical device that received FDA 510(k) clearance on 1992-11-17. The listed applicant is Isolab, Inc.. The 510(k) number is K921681.

When did CRITERION, HEMOCUE B-HEMOGLOBIN CONTROL receive FDA 510(k) clearance?

CRITERION, HEMOCUE B-HEMOGLOBIN CONTROL received FDA 510(k) clearance on 1992-11-17, under 510(k) number K921681.

Who is the listed applicant for CRITERION, HEMOCUE B-HEMOGLOBIN CONTROL?

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

What is the FDA product code for CRITERION, HEMOCUE B-HEMOGLOBIN CONTROL?

The FDA product code for CRITERION, HEMOCUE B-HEMOGLOBIN CONTROL is GGM.

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Other records listing Isolab, Inc. as applicant

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Related Devices (Code: GGM)

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.

K192842HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo HighEurotrol B.V.K182744HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - HighEurotrol B.V.K070546LYPHOCHEK DIABETES CONTROLBio-Rad LaboratoriesK070334R&D SICKLE QC CONTROLR&D Systems, Inc.K052838LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4Bio-RadK032791GLYCOHEMOSURE HBA1C CONTROLQuantimetrix Corp.

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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