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)

MOUSE ANTI-HUMAN LEUCOCYTE ANTIGEN & DAKO PAP KIT

K-Number: K896918 · 1990-08-27

ApplicantDako Corp.
Decision Date1990-08-27
Product CodeDEH
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MOUSE ANTI-HUMAN LEUCOCYTE ANTIGEN & DAKO PAP KIT is the device name listed in this FDA 510(k) record. The listed applicant is Dako Corp.. It received FDA 510(k) clearance on 1990-08-27 under 510(k) number K896918. The device is classified under product code DEH. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOUSE ANTI-HUMAN LEUCOCYTE ANTIGEN & DAKO PAP KIT?

MOUSE ANTI-HUMAN LEUCOCYTE ANTIGEN & DAKO PAP KIT is a medical device that received FDA 510(k) clearance on 1990-08-27. The listed applicant is Dako Corp.. The 510(k) number is K896918.

When did MOUSE ANTI-HUMAN LEUCOCYTE ANTIGEN & DAKO PAP KIT receive FDA 510(k) clearance?

MOUSE ANTI-HUMAN LEUCOCYTE ANTIGEN & DAKO PAP KIT received FDA 510(k) clearance on 1990-08-27, under 510(k) number K896918.

Who is the listed applicant for MOUSE ANTI-HUMAN LEUCOCYTE ANTIGEN & DAKO PAP KIT?

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 MOUSE ANTI-HUMAN LEUCOCYTE ANTIGEN & DAKO PAP KIT?

The FDA product code for MOUSE ANTI-HUMAN LEUCOCYTE ANTIGEN & DAKO PAP KIT is DEH.

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 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

View all 54 devices →

Related Devices (Code: DEH)

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.

K172471VENTANA CD30 (Ber-H2) RxDx AssayVentana Medical Systems, Inc.K083601LAMBDA LIGHT CHAINSSENTINEL CH. SpAK033811FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZERThe Binding Site, Ltd.K031016FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING NEPHELOMETER IIThe Binding Site, Ltd.K023131FREELITE HUMAN LAMBDA FREE KITThe Binding Site, Ltd.K010440FREELITE LAMBDA FREE KITThe Binding Site, Ltd.

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.

↑