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510(k) K002121

Device
TOTAL PSA MICROTITER ELISA
Applicant
ONCOGENE SCIENCE, INC.
510(k) number
K002121
Product code
LTJ  
Decision
Substantially Equivalent (SESE)
Decision date
2000-08-30
Date received
2000-07-13
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
SHERYL BROWN-SHIMER
Address
80 Rogers St. Cambridge MA US 02142 02142

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Legacy Summary#

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FDA Review#

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