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FDA 510(k)

OPTICLONE CD4FITC/CD8 PE MONOCLONAL ANTIBODIES

K-Number: K952789 · 1995-08-14

ApplicantImmunotech Corp.
Decision Date1995-08-14
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

OPTICLONE CD4FITC/CD8 PE MONOCLONAL ANTIBODIES is the device name listed in this FDA 510(k) record. The listed applicant is Immunotech Corp.. It received FDA 510(k) clearance on 1995-08-14 under 510(k) number K952789. 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 OPTICLONE CD4FITC/CD8 PE MONOCLONAL ANTIBODIES?

OPTICLONE CD4FITC/CD8 PE MONOCLONAL ANTIBODIES is a medical device that received FDA 510(k) clearance on 1995-08-14. The listed applicant is Immunotech Corp.. The 510(k) number is K952789.

When did OPTICLONE CD4FITC/CD8 PE MONOCLONAL ANTIBODIES receive FDA 510(k) clearance?

OPTICLONE CD4FITC/CD8 PE MONOCLONAL ANTIBODIES received FDA 510(k) clearance on 1995-08-14, under 510(k) number K952789.

Who is the listed applicant for OPTICLONE CD4FITC/CD8 PE MONOCLONAL ANTIBODIES?

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

What is the FDA product code for OPTICLONE CD4FITC/CD8 PE MONOCLONAL ANTIBODIES?

The FDA product code for OPTICLONE CD4FITC/CD8 PE MONOCLONAL ANTIBODIES is GKZ.

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Other records listing Immunotech 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.

K954188OPTICLONE IGG1 FITC/IGG2A PE ISOTYPIC CONTROLK950626OPTICLONE CD3/CD4 MONOCLONAL ANTIBODIESK931228PROGESTERONE RADIOIMMUNOASSAY KITK911634MICROZYME(TM) FREE T4 ENZYME IMMUNOASSAY TESTK911153MICROZYME PHENCYCLIDINE ENZYME IMMUNOASSAY TEST KTK910411MICROZYME TSH ENZYME IMMUNOASSAY KIT

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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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