The following data is part of a premarket notification filed by W.h.p.m., Inc. with the FDA for First Sign Drug Of Abuse Screening Test.
| Device ID | K032575 |
| 510k Number | K032575 |
| Device Name: | FIRST SIGN DRUG OF ABUSE SCREENING TEST |
| Classification | Enzyme Immunoassay, Amphetamine |
| Applicant | W.H.P.M., INC. 163 CABOT ST. Beverly, MA 01915 |
| Contact | Fran White |
| Correspondent | Fran White W.H.P.M., INC. 163 CABOT ST. Beverly, MA 01915 |
| Product Code | DKZ |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DJC |
| Subsequent Product Code | DJG |
| Subsequent Product Code | DKE |
| Subsequent Product Code | LCM |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-20 |
| Decision Date | 2004-05-19 |
| Summary: | summary |