The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Revised Labeling For Tdx Phencyclidine.
| Device ID | K874484 |
| 510k Number | K874484 |
| Device Name: | REVISED LABELING FOR TDX PHENCYCLIDINE |
| Classification | Radioimmunoassay, Phencyclidine |
| Applicant | ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
| Contact | Mary Zorc |
| Correspondent | Mary Zorc ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
| Product Code | LCL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-30 |
| Decision Date | 1987-11-23 |