The following data is part of a premarket notification filed by Ameritek, Inc. with the FDA for Dbset Multidrug Screen Test Kit.
| Device ID | K990681 |
| 510k Number | K990681 |
| Device Name: | DBSET MULTIDRUG SCREEN TEST KIT |
| Classification | Enzyme Immunoassay, Amphetamine |
| Applicant | AMERITEK, INC. 7030 35TH AVE., N.E. Seattle, WA 98115 |
| Contact | K. C. Yee |
| Correspondent | K. C. Yee AMERITEK, INC. 7030 35TH AVE., N.E. Seattle, WA 98115 |
| Product Code | DKZ |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DJG |
| Subsequent Product Code | LAF |
| Subsequent Product Code | LDJ |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-02 |
| Decision Date | 1999-07-15 |