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FDA 510(k)

COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-II

K-Number: K883836 · 1988-11-30

ApplicantCoulter Immunology
Decision Date1988-11-30
Product CodeGGK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-II is the device name listed in this FDA 510(k) record. The listed applicant is Coulter Immunology. It received FDA 510(k) clearance on 1988-11-30 under 510(k) number K883836. 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 COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-II?

COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-II is a medical device that received FDA 510(k) clearance on 1988-11-30. The listed applicant is Coulter Immunology. The 510(k) number is K883836.

When did COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-II receive FDA 510(k) clearance?

COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-II received FDA 510(k) clearance on 1988-11-30, under 510(k) number K883836.

Who is the listed applicant for COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-II?

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

What is the FDA product code for COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-II?

The FDA product code for COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-II is GGK.

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Other records listing Coulter Immunology 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.

K922744CYTO-STAT/COULTER CLONE CD 3(IGG1)-FITC/T8-RD1K922745CYTO-STAT/COULTER CLONE CD3(IGG1)-FITC/T4-RD1K910473CYTO-STAT(R)/COULTER CLONE(R) T11-RD1/B4-FITCK911793COULTERCLONEK893852COULTER CLONE T4 MONOCLONAL ANTIBODYK893853COULTER CLONE T8 MONOCLONAL ANTIBODY

View all 16 devices →

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.

K883991KVM HEMOGLOBIN LYSING REAGENTKvm Technologies, Inc.K874054FISHER 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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