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FDA 510(k)

ZYMMUNE(TM) CD4/CD8 CELL MONITORING KIT

K-Number: K933878 · 1995-11-14

ApplicantIntracel Corp.
Decision Date1995-11-14
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ZYMMUNE(TM) CD4/CD8 CELL MONITORING KIT is the device name listed in this FDA 510(k) record. The listed applicant is Intracel Corp.. It received FDA 510(k) clearance on 1995-11-14 under 510(k) number K933878. 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 ZYMMUNE(TM) CD4/CD8 CELL MONITORING KIT?

ZYMMUNE(TM) CD4/CD8 CELL MONITORING KIT is a medical device that received FDA 510(k) clearance on 1995-11-14. The listed applicant is Intracel Corp.. The 510(k) number is K933878.

When did ZYMMUNE(TM) CD4/CD8 CELL MONITORING KIT receive FDA 510(k) clearance?

ZYMMUNE(TM) CD4/CD8 CELL MONITORING KIT received FDA 510(k) clearance on 1995-11-14, under 510(k) number K933878.

Who is the listed applicant for ZYMMUNE(TM) CD4/CD8 CELL MONITORING KIT?

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

What is the FDA product code for ZYMMUNE(TM) CD4/CD8 CELL MONITORING KIT?

The FDA product code for ZYMMUNE(TM) CD4/CD8 CELL MONITORING KIT is GKZ.

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Other records listing Intracel Corp. 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.

K003204BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KITK991074BARTELS LEGIONELLA URINARY ANTIGEN ELISA TESTK990664PRIMA SYSTEM - OLD, BARTELS ELISA - NEWK982311BARTELS CINAKIT CMV ANTIGENEMIA

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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