The following data is part of a premarket notification filed by Centocor, Inc. with the FDA for Centocor Ca 15-3 Ria Model No. 800-033.
| Device ID | K963803 |
| 510k Number | K963803 |
| Device Name: | CENTOCOR CA 15-3 RIA MODEL NO. 800-033 |
| Classification | System, Test, Immunological, Antigen, Tumor |
| Applicant | CENTOCOR, INC. 200 GREAT VALLEY PKWY. Malvern, PA 19355 -1307 |
| Contact | Christopher Zalesky |
| Correspondent | Christopher Zalesky CENTOCOR, INC. 200 GREAT VALLEY PKWY. Malvern, PA 19355 -1307 |
| Product Code | MOI |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-23 |
| Decision Date | 1997-05-23 |
| Summary: | summary |