The following data is part of a premarket notification filed by Technicon Instruments Corp. with the FDA for Drug Of Abuse Analysis System.
| Device ID | K903825 |
| 510k Number | K903825 |
| Device Name: | DRUG OF ABUSE ANALYSIS SYSTEM |
| Classification | Enzyme Immunoassay, Barbiturate |
| Applicant | TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Contact | Thomas C Brewster |
| Correspondent | Thomas C Brewster TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Product Code | DIS |
| CFR Regulation Number | 862.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-20 |
| Decision Date | 1990-09-27 |