PMA supplement
P850009 S006: CA 125 ANTIBODY RIA
FDA PMA supplement · Normal 180 Day Track · Centocor, Inc.
Key facts
| Original PMA | P850009 |
|---|---|
| Supplement number | S006 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | CA 125 ANTIBODY RIA |
| Generic name | TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125) |
| Applicant | Centocor, Inc. |
| Product code | LTK |
| Received date | Sep 15, 1993 |
| Decision date | Mar 23, 1994 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: