The following data is part of a premarket notification filed by Consolidated Technologies, Inc. with the FDA for Reference Material For Amphetamine/methamphetamine In Human Urine.
| Device ID | K974699 |
| 510k Number | K974699 |
| Device Name: | REFERENCE MATERIAL FOR AMPHETAMINE/METHAMPHETAMINE IN HUMAN URINE |
| Classification | Calibrators, Drug Mixture |
| Applicant | CONSOLIDATED TECHNOLOGIES, INC. 2170 WOODWARD STREET, STE. 100 Austin, TX 78744 -1832 |
| Contact | William Cone |
| Correspondent | William Cone CONSOLIDATED TECHNOLOGIES, INC. 2170 WOODWARD STREET, STE. 100 Austin, TX 78744 -1832 |
| Product Code | DKB |
| CFR Regulation Number | 862.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-16 |
| Decision Date | 1998-01-22 |