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FDA 510(k)

SIMULTEST CD3/ANTI-HLA-DR

K-Number: K924587 · 1993-08-05

ApplicantBecton Dickinson Immunocytometry Systems
Decision Date1993-08-05
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SIMULTEST CD3/ANTI-HLA-DR is the device name listed in this FDA 510(k) record. The listed applicant is Becton Dickinson Immunocytometry Systems. It received FDA 510(k) clearance on 1993-08-05 under 510(k) number K924587. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIMULTEST CD3/ANTI-HLA-DR?

SIMULTEST CD3/ANTI-HLA-DR is a medical device that received FDA 510(k) clearance on 1993-08-05. The listed applicant is Becton Dickinson Immunocytometry Systems. The 510(k) number is K924587.

When did SIMULTEST CD3/ANTI-HLA-DR receive FDA 510(k) clearance?

SIMULTEST CD3/ANTI-HLA-DR received FDA 510(k) clearance on 1993-08-05, under 510(k) number K924587.

Who is the listed applicant for SIMULTEST CD3/ANTI-HLA-DR?

The FDA 510(k) record lists Becton Dickinson Immunocytometry Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIMULTEST CD3/ANTI-HLA-DR?

The FDA product code for SIMULTEST CD3/ANTI-HLA-DR is GKZ.

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Other records listing Becton Dickinson Immunocytometry Systems 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.

K040026BD FACS 7-COLOR SETUP BEADSK040725BD FACSCANTO SYSTEMK980858MULTITEST CD3/CD16+56/CD45/CD19 REAGENT AND MULTITEST IMK KIT LYSING SOLUTIONK974360MULTITEST CD3/CD8/CD45/CD4K973483FACSCOMP SOFTWARE AND CALIBRITE BEADS FOR USE IN FLOW CYTOMETER INSTRUMENT SETK971205TRI TEST REAGENT CD4 FIT C/CD8 PE/CD3 PERCP WITH TRUCOUNT ABSOLUTE COUNT TUBES

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Related Devices (Code: GKZ)

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.

K260781Yumizen H550HORIBA ABX SASK253212XR-Series (XR-10, XR-20) Automated Hematology AnalyzersSysmex America, Inc.K243348Athelas HomeAthelas, Inc.K251249Tru Hematology TestTruvian Sciences, Inc.K250943Sysmex XR-Series (XR-10) Automated Hematology AnalyzerSysmex America, Inc.K251371Sysmex XR-Series (XR-20) Automated Hematology AnalyzerSysmex America, 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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