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FDA 510(k)

HEMOTOLOGY PRODU&TS (5 IN ALL)

K-Number: K770803 · 1977-07-05

ApplicantHycel, Inc.
Decision Date1977-07-05
Product CodeGKK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOTOLOGY PRODU&TS (5 IN ALL) is the device name listed in this FDA 510(k) record. The listed applicant is Hycel, Inc.. It received FDA 510(k) clearance on 1977-07-05 under 510(k) number K770803. 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 HEMOTOLOGY PRODU&TS (5 IN ALL)?

HEMOTOLOGY PRODU&TS (5 IN ALL) is a medical device that received FDA 510(k) clearance on 1977-07-05. The listed applicant is Hycel, Inc.. The 510(k) number is K770803.

When did HEMOTOLOGY PRODU&TS (5 IN ALL) receive FDA 510(k) clearance?

HEMOTOLOGY PRODU&TS (5 IN ALL) received FDA 510(k) clearance on 1977-07-05, under 510(k) number K770803.

Who is the listed applicant for HEMOTOLOGY PRODU&TS (5 IN ALL)?

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

What is the FDA product code for HEMOTOLOGY PRODU&TS (5 IN ALL)?

The FDA product code for HEMOTOLOGY PRODU&TS (5 IN ALL) is GKK.

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Other records listing Hycel, Inc. 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.

K802422HYCEL TRIGYCERIDE II TESTK790335HYCEL MK782116KETOSTEROID TEST, HYCEL-17K782176HYCEL LDH-INT TESTK782100HYCEL COUNTER 333K782102HYCEL COUNTER 211

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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.K771090UNIPAK HEMOGLOBINHarleco

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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