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FDA 510(k)

OPTICLONE IGG1 FITC/IGG1 PE ISOTYPIC CONTROL

K-Number: K953498 · 1995-09-08

ApplicantImmunotech, Inc.
Decision Date1995-09-08
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

OPTICLONE IGG1 FITC/IGG1 PE ISOTYPIC CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Immunotech, Inc.. It received FDA 510(k) clearance on 1995-09-08 under 510(k) number K953498. 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 IGG1 FITC/IGG1 PE ISOTYPIC CONTROL?

OPTICLONE IGG1 FITC/IGG1 PE ISOTYPIC CONTROL is a medical device that received FDA 510(k) clearance on 1995-09-08. The listed applicant is Immunotech, Inc.. The 510(k) number is K953498.

When did OPTICLONE IGG1 FITC/IGG1 PE ISOTYPIC CONTROL receive FDA 510(k) clearance?

OPTICLONE IGG1 FITC/IGG1 PE ISOTYPIC CONTROL received FDA 510(k) clearance on 1995-09-08, under 510(k) number K953498.

Who is the listed applicant for OPTICLONE IGG1 FITC/IGG1 PE ISOTYPIC CONTROL?

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

What is the FDA product code for OPTICLONE IGG1 FITC/IGG1 PE ISOTYPIC CONTROL?

The FDA product code for OPTICLONE IGG1 FITC/IGG1 PE ISOTYPIC CONTROL is GKZ.

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Other records listing Immunotech, 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.

K946335OPTICLONE(TM CD3 FITC/CD19 PE MONOCLONAL ANTIBODIESK952182OPTICLONE CD3/CD8 MONOCLONAL ANTIBODIES

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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