The following data is part of a premarket notification filed by Starplex Scientific, Inc. with the FDA for Startox Drug Of Abuse Screening Test.
| Device ID | K021006 |
| 510k Number | K021006 |
| Device Name: | STARTOX DRUG OF ABUSE SCREENING TEST |
| Classification | Enzyme Immunoassay, Amphetamine |
| Applicant | STARPLEX SCIENTIFIC, INC. 163 CABOT ST. Beverly, MA 01915 |
| Contact | Fran White |
| Correspondent | Fran White STARPLEX SCIENTIFIC, INC. 163 CABOT ST. Beverly, MA 01915 |
| Product Code | DKZ |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DJG |
| Subsequent Product Code | LCM |
| Subsequent Product Code | LDJ |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-28 |
| Decision Date | 2002-06-10 |
| Summary: | summary |