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510(k) K003963

Device
DIMENSION PSA FLEX REAGENT CARTRIDGE
Applicant
DADE BEHRING, INC.
510(k) number
K003963
Product code
LTJ  
Decision
Substantially Equivalent (SESE)
Decision date
2001-02-28
Date received
2000-12-22
Regulation
866.6010
Classification name
Prostate-specific Antigen (psa) For Management Of Prostate Cancers
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
GEORGE M PLUMMER
Address
Glasgow Business Community; Bldg. 500 P.O. Box 6101 Newark DE US 19714 19714

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Legacy Summary#

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FDA Review#

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