PMA P980018S002

Device: DAKOCYTOMATION HERCEP TEST
Applicant: Agilent Technologies Singapore (International) Pte , Ltd.
PMA number: P980018
Supplement: S002
Product code: MVC
Decision date: 2003-06-11
Classification: System, Test, Her-2/neu, Ihc
Generic name: SYSTEM, TEST, HER-2/NEU, IHC
Approval order statement: CHANGE IN THE MANUFACTURING METHOD FOR THE CONJUGATION OF THE TWO PROTEINS TO THE ACTIVATED DEXTRAN TO ONE STEP FOLLOWED BY ONLY ONE PURIFICATION STEP.

Current openFDA PMA Record#

Device: DAKOCYTOMATION HERCEP TEST
Applicant: Agilent Technologies Singapore (International) Pte , Ltd.
PMA number: P980018
Supplement: S002
Product code: MVC
Generic name: SYSTEM, TEST, HER-2/NEU, IHC
Decision date: 2003-06-11
Decision code: OK30
Date received: 2003-05-14
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE IN THE MANUFACTURING METHOD FOR THE CONJUGATION OF THE TWO PROTEINS TO THE ACTIVATED DEXTRAN TO ONE STEP FOLLOWED BY ONLY ONE PURIFICATION STEP.