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PMA P920048S011

Device
RAPID FFN FOR THE TLIIQ SYSTEM
Applicant
Hologic, Inc.
PMA number
P920048
Supplement
S011
Product code
LKV
Decision date
2016-02-05
Classification
Enzyme Immunoassay, Fetal Fibronectin
Generic name
ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
Approval order statement
Approval for design modifications to the cassette inner housing of your Rapid fFN test, to the pneumatic press plate used in the automated manufacturing process, and for introduction of a thickness gauge in the automated manufacturing process.

Current openFDA PMA Record#

Device
RAPID FFN FOR THE TLIIQ SYSTEM
Applicant
Hologic, Inc.
PMA number
P920048
Supplement
S011
Product code
LKV
Generic name
ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
Decision date
2016-02-05
Decision code
APPR
Date received
2015-06-10
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for design modifications to the cassette inner housing of your Rapid fFN test, to the pneumatic press plate used in the automated manufacturing process, and for introduction of a thickness gauge in the automated manufacturing process.