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FDA 510(k)

CALTAG CD4 R-PE MONOCLONAL ANTIBODY

K-Number: K944128 · 1995-06-20

ApplicantCaltag Laboratories, Inc.
Decision Date1995-06-20
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CALTAG CD4 R-PE MONOCLONAL ANTIBODY is the device name listed in this FDA 510(k) record. The listed applicant is Caltag Laboratories, Inc.. It received FDA 510(k) clearance on 1995-06-20 under 510(k) number K944128. 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 CALTAG CD4 R-PE MONOCLONAL ANTIBODY?

CALTAG CD4 R-PE MONOCLONAL ANTIBODY is a medical device that received FDA 510(k) clearance on 1995-06-20. The listed applicant is Caltag Laboratories, Inc.. The 510(k) number is K944128.

When did CALTAG CD4 R-PE MONOCLONAL ANTIBODY receive FDA 510(k) clearance?

CALTAG CD4 R-PE MONOCLONAL ANTIBODY received FDA 510(k) clearance on 1995-06-20, under 510(k) number K944128.

Who is the listed applicant for CALTAG CD4 R-PE MONOCLONAL ANTIBODY?

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

What is the FDA product code for CALTAG CD4 R-PE MONOCLONAL ANTIBODY?

The FDA product code for CALTAG CD4 R-PE MONOCLONAL ANTIBODY is GKZ.

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Other records listing Caltag Laboratories, 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.

K990641CALTAG FETAL HEMOGLOBIN TESTK965232CALTAG CAL-LYSEK964856CD3 FITC/CD19 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATIONK963954CD 19 R-PE, CD19 TRI-COLOR MONOCLONAL ANTIBODYK950916CD3 FITC/CD8 R-PE MONOCLONAL ANTIBODY COMBINATIONK951073CD3 TRI-COLOR/CD4 R-PE/CD8 FITC MONOCLONAL ANTIBODY COMBINATION

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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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