The following data is part of a premarket notification filed by Consolidated Technologies, Inc. with the FDA for Reference Material For Phencyclidine In Human Urine.
| Device ID | K933557 |
| 510k Number | K933557 |
| Device Name: | REFERENCE MATERIAL FOR PHENCYCLIDINE IN HUMAN URINE |
| Classification | Drug Specific Control Materials |
| Applicant | CONSOLIDATED TECHNOLOGIES, INC. 2170 WOODWARD STREET, STE. 100 Austin, TX 78744 -1832 |
| Contact | E. Kay Robinson |
| Correspondent | E. Kay Robinson CONSOLIDATED TECHNOLOGIES, INC. 2170 WOODWARD STREET, STE. 100 Austin, TX 78744 -1832 |
| Product Code | LAS |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-21 |
| Decision Date | 1993-09-10 |