PMA P120012S009

Device: ABBOTT REALTIME HCV GENOTYPE II
Applicant: Abbott Molecular
PMA number: P120012
Supplement: S009
Product code: OBF
Decision date: 2015-10-09
Classification: Assay, Genotyping, Hepatitis C Virus
Generic name: Assay, genotyping, hepatitis c virus
Approval order statement: APPROVAL FOR TWO CHANGES TO THE APPLICATION SPECIFICATION FILES TO EXTEND THE CHILLER DELAY TIMER AND CHANGE THE CONDUCTIVITY SETTING FOR THE DETECTION OF RNA WASH2 LIQUID.

Current openFDA PMA Record#

Device: ABBOTT REALTIME HCV GENOTYPE II
Applicant: Abbott Molecular
PMA number: P120012
Supplement: S009
Product code: OBF
Generic name: Assay, genotyping, hepatitis c virus
Decision date: 2015-10-09
Decision code: APPR
Date received: 2015-07-29
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR TWO CHANGES TO THE APPLICATION SPECIFICATION FILES TO EXTEND THE CHILLER DELAY TIMER AND CHANGE THE CONDUCTIVITY SETTING FOR THE DETECTION OF RNA WASH2 LIQUID.