PMA P980018S006

Device: HERCEP TEST
Applicant: Agilent Technologies Singapore (International) Pte , Ltd.
PMA number: P980018
Supplement: S006
Product code: MVC
Decision date: 2010-02-25
Classification: System, Test, Her-2/neu, Ihc
Generic name: SYSTEM, TEST, HER-2/NEU, IHC
Approval order statement: APPROVAL TO MARKET THE HERCEPTEST KIT FOR AUTOMATED LINK PLATFORMS AND THE CHANGES INVOLVED IN THE ASSAY PROCEDURE TO USE THE NEW INSTRUMENT, CHANGE IN THE QC PROCEDURE WITH REFERENCE TO CHROMOGEN, CHANGES IN THE CRITERIA REGARDING THE CONTROL TISSUE DURING QC AND CHANGES IN THE SPECIMEN PREPARATION.

Current openFDA PMA Record#

Device: HERCEP TEST
Applicant: Agilent Technologies Singapore (International) Pte , Ltd.
PMA number: P980018
Supplement: S006
Product code: MVC
Generic name: SYSTEM, TEST, HER-2/NEU, IHC
Decision date: 2010-02-25
Decision code: APPR
Date received: 2008-05-28
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL TO MARKET THE HERCEPTEST KIT FOR AUTOMATED LINK PLATFORMS AND THE CHANGES INVOLVED IN THE ASSAY PROCEDURE TO USE THE NEW INSTRUMENT, CHANGE IN THE QC PROCEDURE WITH REFERENCE TO CHROMOGEN, CHANGES IN THE CRITERIA REGARDING THE CONTROL TISSUE DURING QC AND CHANGES IN THE SPECIMEN PREPARATION.