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PMA P980024S005

Device
PATHVYSION HER-2 DNA PROBE KIT
Applicant
Abbott Molecular, Inc.
PMA number
P980024
Supplement
S005
Product code
MVD
Decision date
2011-04-18
Classification
System, Test, Her-2/neu, Nucleic Acid Or Serum
Generic name
SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
Approval order statement
APPROVAL FOR THE IMPLEMENTATION OF PROCESS CHANGES TO THE MANUFACTURE OF THE PATHVYSION HER-2 DNA PROBE KIT ASSAY, INCLUDING A NEW FISH DNA EXTRACTION PROCESS, AND RNA REDUCTION STEP, NEW SONICATION EQUIPMENT, AND A NEW AMINATION/LABELING PROCEDURE.

Current openFDA PMA Record#

Device
PATHVYSION HER-2 DNA PROBE KIT
Applicant
Abbott Molecular, Inc.
PMA number
P980024
Supplement
S005
Product code
MVD
Generic name
SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
Decision date
2011-04-18
Decision code
APPR
Date received
2011-02-22
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL FOR THE IMPLEMENTATION OF PROCESS CHANGES TO THE MANUFACTURE OF THE PATHVYSION HER-2 DNA PROBE KIT ASSAY, INCLUDING A NEW FISH DNA EXTRACTION PROCESS, AND RNA REDUCTION STEP, NEW SONICATION EQUIPMENT, AND A NEW AMINATION/LABELING PROCEDURE.