MONOCLONAL MOUSE ANTI-HUMAN CD30, KI-1 ANTIGEN, BER-H2 ANTIBODY FOR IMMUNOENZYMATIC STAINING (PRODUCT CODE NO. MO751)— 510(k) K965022

Name: FDA 510(k) clearance K965022
Creator: U.S. Food and Drug Administration
Published: 1997-11-06

Substantially Equivalent

Dako Corp.

FDA 510(k) clearance K965022 for MONOCLONAL MOUSE ANTI-HUMAN CD30, KI-1 ANTIGEN, BER-H2 ANTIBODY FOR IMMUNOENZYMATIC STAINING (PRODUCT CODE NO. MO751), Substantially Equivalent on 1997-11-06. Applicant: Dako Corp.. Device class: 2.

Clearance details

Applicant: Dako Corp.
Product code: Code DEH
Device class: Class 2
Regulation: 21 CFR 866.5550
Advisory panel: Immunology
Date received: 1996-12-16
Decision date: 1997-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carpinteria, CA, US

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