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 Urine Screening Test.
| Device ID | K052197 |
| 510k Number | K052197 |
| Device Name: | FIRST SIGN DRUG OF ABUSE URINE SCREENING TEST |
| Classification | Enzyme Immunoassay, Methadone |
| 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 | DJR |
| Subsequent Product Code | DIS |
| Subsequent Product Code | DJG |
| Subsequent Product Code | JXM |
| Subsequent Product Code | LAF |
| Subsequent Product Code | LFG |
| CFR Regulation Number | 862.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-12 |
| Decision Date | 2006-06-09 |
| Summary: | summary |