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FDA 510(k)

CYMET-PLUS

K-Number: K771716 · 1977-09-20

ApplicantJ.T. Baker Chemical Co.
Decision Date1977-09-20
Product CodeGKK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CYMET-PLUS is the device name listed in this FDA 510(k) record. The listed applicant is J.T. Baker Chemical Co.. It received FDA 510(k) clearance on 1977-09-20 under 510(k) number K771716. 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 CYMET-PLUS?

CYMET-PLUS is a medical device that received FDA 510(k) clearance on 1977-09-20. The listed applicant is J.T. Baker Chemical Co.. The 510(k) number is K771716.

When did CYMET-PLUS receive FDA 510(k) clearance?

CYMET-PLUS received FDA 510(k) clearance on 1977-09-20, under 510(k) number K771716.

Who is the listed applicant for CYMET-PLUS?

The FDA 510(k) record lists J.T. Baker Chemical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CYMET-PLUS?

The FDA product code for CYMET-PLUS is GKK.

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Other records listing J.T. Baker Chemical Co. as applicant

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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 ElectronicsK771090UNIPAK HEMOGLOBINHarlecoK770803HEMOTOLOGY 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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