Company · US
W.H.P.M., Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2001 to 2022. Name variants (Inc, Corp, punctuation) are merged.
14510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DJR | Enzyme Immunoassay, Methadone | 3 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 2 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 1 |
| DJG | Enzyme Immunoassay, Opiates | 1 |
| DKZ | Enzyme Immunoassay, Amphetamine | 1 |
| KHE | Reagent, Occult Blood | 1 |
| LAF | Gas Chromatography, Methamphetamine | 1 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 1 |
| NFT | Test, Amphetamine, Over The Counter | 1 |
| OOX | Automated Occult Blood Analyzer | 1 |
| QBF | Test, Propoxyphene, Over The Counter | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 2, 2022 | K200754 | Hemosure Accu-Reader A100 W.H.P.M., Inc. | OOX |
| Aug 12, 2021 | K210327 | First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign Multi-Drug Screen Test Dip Card, First S W.H.P.M., Inc. | QBF |
| Feb 5, 2018 | K171695 | First Sign Multi-Drug Dip Card Test, First Sign Multi-Drug Cup Test, First Sign Drug of Abuse Dip Card Test Marijuana, F W.H.P.M., Inc. | NFT |
| Aug 17, 2016 | K160793 | First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortr W.H.P.M., Inc. | DJR |
| Nov 9, 2015 | K152551 | First Sign® Drug of Abuse Buprenorphine Cup Test, First Sign® Drug of Abuse Buprenorphine Dip Card Test, First Sign® Dru W.H.P.M., Inc. | DJG |
| Jun 29, 2015 | K151441 | First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test W.H.P.M., Inc. | DJR |
| Feb 26, 2015 | K150162 | First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test W.H.P.M., Inc. | LAF |
| Oct 7, 2014 | K142353 | First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup Test W.H.P.M., Inc. | DIO |
| Jun 9, 2006 | K052197 | FIRST SIGN DRUG OF ABUSE URINE SCREENING TEST W.H.P.M., Inc. | DJR |
| Aug 22, 2005 | K051841 | WH ACCU TEST ONE-STEP URINE/SERUM COMBO PREGNANCY TEST W.H.P.M., Inc. | JHI |
| Aug 12, 2004 | K041202 | HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST W.H.P.M., Inc. | KHE |
| May 20, 2004 | K041273 | ONE-STEP PREGNANCY TEST W.H.P.M., Inc. | LCX |
| May 19, 2004 | K032575 | FIRST SIGN DRUG OF ABUSE SCREENING TEST W.H.P.M., Inc. | DKZ |
| Aug 28, 2001 | K012284 | WH ACCU TEST PREGNANCY TEST W.H.P.M., Inc. | JHI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||