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 Dip Card Test/first Sign Drug Of Abuse Cup Test.
| Device ID | K142353 |
| 510k Number | K142353 |
| Device Name: | First Sign Drug Of Abuse Dip Card Test/First Sign Drug Of Abuse Cup Test |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Applicant | W.H.P.M., Inc. 5358 Irwindale Ave Irwindale, CA 91706 |
| Contact | John Wan |
| Correspondent | Joe Shia LSI INTERNATIONAL INC. 504 EAST DIAMOND AVE. SUITE I Gaithersburg, MD 20877 |
| Product Code | DIO |
| Subsequent Product Code | DKZ |
| Subsequent Product Code | LDJ |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-21 |
| Decision Date | 2014-10-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B2983014010 | K142353 | 000 |
| B2983013010 | K142353 | 000 |
| B2983011010 | K142353 | 000 |
| B2983031010 | K142353 | 000 |
| B2983020010 | K142353 | 000 |
| B29830140C10 | K142353 | 000 |
| B29830130C10 | K142353 | 000 |
| B29830110C10 | K142353 | 000 |