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FDA 510(k)

UNIPAK HEMOGLOBIN

K-Number: K771090 · 1977-07-11

ApplicantHarleco
Decision Date1977-07-11
Product CodeGKK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

UNIPAK HEMOGLOBIN is the device name listed in this FDA 510(k) record. The listed applicant is Harleco. It received FDA 510(k) clearance on 1977-07-11 under 510(k) number K771090. The device is classified under product code GKK. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNIPAK HEMOGLOBIN?

UNIPAK HEMOGLOBIN is a medical device that received FDA 510(k) clearance on 1977-07-11. The listed applicant is Harleco. The 510(k) number is K771090.

When did UNIPAK HEMOGLOBIN receive FDA 510(k) clearance?

UNIPAK HEMOGLOBIN received FDA 510(k) clearance on 1977-07-11, under 510(k) number K771090.

Who is the listed applicant for UNIPAK HEMOGLOBIN?

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

What is the FDA product code for UNIPAK HEMOGLOBIN?

The FDA product code for UNIPAK HEMOGLOBIN is GKK.

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Other records listing Harleco as applicant

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.

K820233ULTRAZYME PLUS GAMMA GT(65055-65056)K813427ULTRACHEM GLUC-DHK813044ULTRACHEM ALB, ITEM #64970K813042ULTRACHEM GLUC-DH SET, ITEM #65048K813038ULTRACHEM TP, ITEM #64974K813041ULTRAZYME-GT, ITEM #64959 & 65032

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Related Devices (Code: GKK)

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.

K896922RAICHEM TM HEMOGLOBIN REAGENTReagents Applications, Inc.K894951MODIFIED HEMOGLOBIN REAGENT SETMacomb Biotechnology, Inc.K883992KVM PREPACK HEMATOLOGY REAGENT SETKvm Technologies, Inc.K821202HEMOGLOBIN REAGENT SETOmega Medical ElectronicsK771716CYMET-PLUSJ.T. Baker Chemical Co.K770803HEMOTOLOGY PRODU&TS (5 IN ALL)Hycel, Inc.

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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