The following data is part of a premarket notification filed by W.h.p.m., Inc. with the FDA for First Sign Multi-drug Test Dip Card, First Sign Multi-drug Test Cup, First Sign Multi-drug Screen Test Dip Card, First Sign Multi-drug Screen Test Cup.
| Device ID | K210327 |
| 510k Number | K210327 |
| Device Name: | First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign Multi-Drug Screen Test Dip Card, First Sign Multi-Drug Screen Test Cup |
| Classification | Test, Propoxyphene, Over The Counter |
| Applicant | W.H.P.M., Inc. 5358 Irwindale Ave. Irwindale, CA 91706 |
| Contact | John Wan |
| Correspondent | Joe Shia LSI Consulting 504E Diamond Ave., Suite I Gaithersburg, MD 20877 |
| Product Code | QBF |
| Subsequent Product Code | LCM |
| Subsequent Product Code | NFT |
| Subsequent Product Code | NFV |
| Subsequent Product Code | NFW |
| Subsequent Product Code | NFY |
| Subsequent Product Code | NGG |
| Subsequent Product Code | NGL |
| Subsequent Product Code | PTG |
| Subsequent Product Code | PTH |
| Subsequent Product Code | QAW |
| CFR Regulation Number | 862.3700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-04 |
| Decision Date | 2021-08-12 |