WHPM Inc.
Irwindale, CA, US
W.H.P.M., INC. appears in FDA device records in Irwindale, CA. FDA records list 8 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for WHPM Inc. between 2014 and 2022. The busiest year on record is 2015, with 3. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2014 | 1 |
| 2015 | 3 |
| 2016 | 1 |
| 2018 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K200754 | Hemosure Accu-Reader A100 | OOX | Substantially Equivalent | |
| K210327 | 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 | QBF | Substantially Equivalent | |
| K171695 | First Sign Multi-Drug Dip Card Test, First Sign Multi-Drug Cup Test, First Sign Drug of Abuse Dip Card Test Marijuana, First Sign Drug of Abuse Cup Test Marijuana | NFT | Substantially Equivalent | |
| K160793 | First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline) | DJR | Substantially Equivalent | |
| K152551 | First Sign® Drug of Abuse Buprenorphine Cup Test, First Sign® Drug of Abuse Buprenorphine Dip Card Test, First Sign® Drug of Abuse Butalbital Cup Test, First Sign® Drug of Abuse Butalbital Dip Card Test, First Sign® Drug of Abuse Morphine Cup Test, First Sign® Drug of Abuse Morphine Dip Card Test. | DJG | Substantially Equivalent | |
| K151441 | First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test | DJR | Substantially Equivalent | |
| K150162 | First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test | LAF | Substantially Equivalent | |
| K142353 | First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup Test | DIO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2087033 | 3003102569 | W.H.P.M., INC. | 5358 Irwindale Ave, Irwindale, CA 91706 US | 2026 | and 26 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- OOXAutomated Occult Blood Analyzer
- NZUCollector, Urine, Powered, Non Indwelling Catheter
- DKZEnzyme Immunoassay, Amphetamine
- DISEnzyme Immunoassay, Barbiturate
- JXMEnzyme Immunoassay, Benzodiazepine
- LDJEnzyme Immunoassay, Cannabinoids
- DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
- DJREnzyme Immunoassay, Methadone
- DJGEnzyme Immunoassay, Opiates
- LCMEnzyme Immunoassay, Phencyclidine
- LAFGas Chromatography, Methamphetamine
- LCXKit, Test, Pregnancy, Hcg, Over The Counter
- LFGRadioimmunoassay, Tricyclic Antidepressant Drugs
- KHEReagent, Occult Blood
- DKEReagents, Test, Tetrahydrocannabinol
- PUXTest, Amphetamine, Employment And Insurance Testing, Exempt
- NFTTest, Amphetamine, Over The Counter
- PUYTest, Barbiturate, Employment And Insurance Testing, Exempt
- PTHTest, Barbiturate, Over The Counter
- PUZTest, Benzodiazepine, Employment And Insurance Testing, Exempt
- NFVTest, Benzodiazepine, Over The Counter
- PVJTest, Cannabinoid, Employment And Insurance Testing, Exempt
- NFWTest, Cannabinoid, Over The Counter
- PVATest, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt
- NFYTest, Cocaine And Cocaine Metabolites, Over The Counter
- NGATest, Follicle Stimulating Hormone (Fsh), Over The Counter
- NGETest, Luteinizing Hormone (Lh), Over The Counter
- PVETest, Methadone, Employment And Insurance Testing, Exempt
- PTGTest, Methadone, Over The Counter
- PVDTest, Methamphetamine, Employment And Insurance Testing, Exempt
- NGGTest, Methamphetamine, Over The Counter
- PVHTest, Opiates, Employment And Insurance Testing, Exempt
- NGLTest, Opiates, Over The Counter
- QBFTest, Propoxyphene, Over The Counter
- QAWTest, Tricyclic Antidepressants, Over The Counter
- DJCThin Layer Chromatography, Methamphetamine
- JHIVisual, Pregnancy Hcg, Prescription Use
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0892-2022 | First SIGN SARS-CoV-2 Antigen Test | Frm became aware that a customer complaint was reported to US FDA that SARS-CoV-2 Antigen Tests were sold domestically by a pharmacy in California. These Antigen Tests have not received FDA Emergency Use Authorization, nor have these tests been cleared or approved by FDA for commercial distribution in the U.S. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain