CA 125 ANTIBODY RIA

FDA Premarket Approval P850009 S002

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

DeviceCA 125 ANTIBODY RIA
Generic NameTest, Epithelial Ovarian Tumor-associated Antigen (ca125)
ApplicantCENTOCOR, INC.
Date Received1989-10-27
Decision Date1990-02-13
PMAP850009
SupplementS002
Product CodeLTK 
Advisory CommitteeImmunology
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address CENTOCOR, INC. 200 Great Valley Pkwy. malvern, PA 19355-1307

Supplemental Filings

Supplement NumberDateSupplement Type
P850009Original Filing
S007 1993-12-08 Normal 180 Day Track
S006 1993-09-15 Normal 180 Day Track
S005 1992-01-23 Normal 180 Day Track
S004 1990-11-28 Normal 180 Day Track
S003
S002 1989-10-27 Normal 180 Day Track
S001 1987-06-08 Normal 180 Day Track

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