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FDA 510(k)

KVM HEMOGLOBIN LYSING REAGENT

K-Number: K883991 · 1988-10-12

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

Device Summary

KVM HEMOGLOBIN LYSING REAGENT 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 K883991. The device is classified under product code GGK. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KVM HEMOGLOBIN LYSING REAGENT?

KVM HEMOGLOBIN LYSING REAGENT 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 K883991.

When did KVM HEMOGLOBIN LYSING REAGENT receive FDA 510(k) clearance?

KVM HEMOGLOBIN LYSING REAGENT received FDA 510(k) clearance on 1988-10-12, under 510(k) number K883991.

Who is the listed applicant for KVM HEMOGLOBIN LYSING REAGENT?

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 HEMOGLOBIN LYSING REAGENT?

The FDA product code for KVM HEMOGLOBIN LYSING REAGENT is GGK.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 DILUENTK883992KVM PREPACK HEMATOLOGY REAGENT SETK883989KVM ISOTONIC FLUSH SOLUTION

Related Devices (Code: GGK)

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.

K883836COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-IICoulter ImmunologyK874054FISHER DIAGNOSTICS HEMATALL III LAS REAGENTFisher Scientific Co., LLCK873348CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG.Abbott DiagnosticsK863114PIASTRINITJ. D. Assoc.K863503HEMOLYSEReagent Laboratory, Inc.K850097LASER-LYSEHematology Marketing Assoc.

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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