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FDA 510(k)

MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD8, RPE-CONJUGATED, CLONE DK25

K-Number: K944253 · 1994-11-21

ApplicantDako Corp.
Decision Date1994-11-21
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD8, RPE-CONJUGATED, CLONE DK25 is the device name listed in this FDA 510(k) record. The listed applicant is Dako Corp.. It received FDA 510(k) clearance on 1994-11-21 under 510(k) number K944253. 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 MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD8, RPE-CONJUGATED, CLONE DK25?

MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD8, RPE-CONJUGATED, CLONE DK25 is a medical device that received FDA 510(k) clearance on 1994-11-21. The listed applicant is Dako Corp.. The 510(k) number is K944253.

When did MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD8, RPE-CONJUGATED, CLONE DK25 receive FDA 510(k) clearance?

MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD8, RPE-CONJUGATED, CLONE DK25 received FDA 510(k) clearance on 1994-11-21, under 510(k) number K944253.

Who is the listed applicant for MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD8, RPE-CONJUGATED, CLONE DK25?

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

What is the FDA product code for MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD8, RPE-CONJUGATED, CLONE DK25?

The FDA product code for MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD8, RPE-CONJUGATED, CLONE DK25 is GKZ.

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Other records listing Dako 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.

K020023DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBODY FOR IMMUNOENZYMATIC STAININGK993957DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTORK991402DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE-CY5, CLONE UCHT1 & DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE, CLONE UCHT1K991454MOUSE IGG1 NEGATIVE CONTROLSK980635DAKO MOUSE ANTI-HUMAN B-CELL, CD19/RPE-CY5, CLONE HD37K971905DAKO MOUSE ANTI HUMAN CYTOKERATIN, HIGH MOLECULAR WEIGHT, CLONE 34BE12, MONOCLONAL ANTIBODY FOR IMMUNOENZYMATIC STAINING

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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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