The following data is part of a premarket notification filed by Centocor, Inc. with the FDA for Centocor Aggrestat, Collagen Reagent, Control Reagent.
| Device ID | K954997 |
| 510k Number | K954997 |
| Device Name: | CENTOCOR AGGRESTAT, COLLAGEN REAGENT, CONTROL REAGENT |
| Classification | System, Automated Platelet Aggregation |
| 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 | JOZ |
| CFR Regulation Number | 864.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-01 |
| Decision Date | 1996-01-24 |