Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CD 19 R-PE, CD19 TRI-COLOR MONOCLONAL ANTIBODY

K-Number: K963954 · 1996-11-25

ApplicantCaltag Laboratories, Inc.
Decision Date1996-11-25
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CD 19 R-PE, CD19 TRI-COLOR 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 1996-11-25 under 510(k) number K963954. 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 CD 19 R-PE, CD19 TRI-COLOR MONOCLONAL ANTIBODY?

CD 19 R-PE, CD19 TRI-COLOR MONOCLONAL ANTIBODY is a medical device that received FDA 510(k) clearance on 1996-11-25. The listed applicant is Caltag Laboratories, Inc.. The 510(k) number is K963954.

When did CD 19 R-PE, CD19 TRI-COLOR MONOCLONAL ANTIBODY receive FDA 510(k) clearance?

CD 19 R-PE, CD19 TRI-COLOR MONOCLONAL ANTIBODY received FDA 510(k) clearance on 1996-11-25, under 510(k) number K963954.

Who is the listed applicant for CD 19 R-PE, CD19 TRI-COLOR 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 CD 19 R-PE, CD19 TRI-COLOR MONOCLONAL ANTIBODY?

The FDA product code for CD 19 R-PE, CD19 TRI-COLOR MONOCLONAL ANTIBODY is GKZ.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 COMBINATIONK950917CD3 FITC/CD8 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATIONK950916CD3 FITC/CD8 R-PE MONOCLONAL ANTIBODY COMBINATIONK951073CD3 TRI-COLOR/CD4 R-PE/CD8 FITC MONOCLONAL ANTIBODY COMBINATION

View all 12 devices →

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.

↑