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FDA 510(k)

KVM PREPACK HEMATOLOGY REAGENT SET

K-Number: K883992 · 1988-10-12

ApplicantKvm Technologies, Inc.
Decision Date1988-10-12
Product CodeGKK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

KVM PREPACK HEMATOLOGY REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Kvm Technologies, Inc.. It received FDA 510(k) clearance on 1988-10-12 under 510(k) number K883992. 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 KVM PREPACK HEMATOLOGY REAGENT SET?

KVM PREPACK HEMATOLOGY REAGENT SET is a medical device that received FDA 510(k) clearance on 1988-10-12. The listed applicant is Kvm Technologies, Inc.. The 510(k) number is K883992.

When did KVM PREPACK HEMATOLOGY REAGENT SET receive FDA 510(k) clearance?

KVM PREPACK HEMATOLOGY REAGENT SET received FDA 510(k) clearance on 1988-10-12, under 510(k) number K883992.

Who is the listed applicant for KVM PREPACK HEMATOLOGY REAGENT SET?

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

What is the FDA product code for KVM PREPACK HEMATOLOGY REAGENT SET?

The FDA product code for KVM PREPACK HEMATOLOGY REAGENT SET is GKK.

Related Clinical Trials

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.

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Other records listing Kvm Technologies, 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.

K925666THERAPACER 3000K883990KVM ISOTONIC DILUENTK883991KVM HEMOGLOBIN LYSING REAGENTK883989KVM ISOTONIC FLUSH SOLUTION

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.K821202HEMOGLOBIN REAGENT SETOmega Medical ElectronicsK771716CYMET-PLUSJ.T. Baker Chemical Co.K771090UNIPAK 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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