The following data is part of a premarket notification filed by Tcpi, Inc. with the FDA for One Step Urine Drug Of Abuse Amphetamine Test.
| Device ID | K981197 |
| 510k Number | K981197 |
| Device Name: | ONE STEP URINE DRUG OF ABUSE AMPHETAMINE TEST |
| Classification | Enzyme Immunoassay, Amphetamine |
| Applicant | TCPI, INC. P.O. BOX 8726 Ft. Lauderdale, FL 33310 |
| Contact | Jack L Aronowitz . |
| Correspondent | Jack L Aronowitz . TCPI, INC. P.O. BOX 8726 Ft. Lauderdale, FL 33310 |
| Product Code | DKZ |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-02 |
| Decision Date | 1998-06-16 |
| Summary: | summary |