Data / Medical devices / China / W.H.P.M. Bioresearch & Technology Co., Ltd.
W.H.P.M. Bioresearch & Technology Co., Ltd.: FDA-registered device maker in Beijing, China, 15 510(k) clearances
W.H.P.M. Bioresearch & Technology Co., Ltd. is registered with the FDA (registration 3005345870) in Beijing, China. It lists 37 device types. The FDA files 15 510(k) clearances under its listings, the newest dated June 2, 2022. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3005345870
- Address
- Building 9, No.9 Tianfu Street Daxing District, Beijing, China, 102629
- Owner or operator
- W.H.P.M. Bioresearch & Technology Co., Ltd. (9076940)
- Roles
- Manufacturer
- First device listed
- August 31, 2005
- Registered through
- 2026
- Brand names listed
- CRLstat, Discover Plus, DrugCheck, ECO I, ECO II, ECO IV, EZ CLICK, FIRST SIGN DRUG OF and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 2, 2022 | K200754 | Hemosure Accu-Reader A100 | OOX | Substantially Equivalent | W.H.P.M., Inc. | accessdata.fda.gov |
| August 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 Sign Multi-Drug Screen Test Cup | QBF | Substantially Equivalent | W.H.P.M., Inc. | accessdata.fda.gov |
| February 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, First Sign Drug of Abuse Cup Test Marijuana | NFT | Substantially Equivalent | W.H.P.M., Inc. | accessdata.fda.gov |
| August 17, 2016 | 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 | W.H.P.M., Inc. | accessdata.fda.gov |
| November 9, 2015 | 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 | W.H.P.M., Inc. | accessdata.fda.gov |
| June 29, 2015 | K151441 | First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test | DJR | Substantially Equivalent | W.H.P.M., Inc. | accessdata.fda.gov |
| February 26, 2015 | K150162 | First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test | LAF | Substantially Equivalent | W.H.P.M., Inc. | accessdata.fda.gov |
| October 7, 2014 | K142353 | First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup Test | DIO | Substantially Equivalent | W.H.P.M., Inc. | accessdata.fda.gov |
| June 9, 2006 | K052197 | FIRST SIGN DRUG OF ABUSE URINE SCREENING TEST | DJR | Substantially Equivalent | W.H.P.M., Inc. | accessdata.fda.gov |
| August 22, 2005 | K051841 | WH ACCU TEST ONE-STEP URINE/SERUM COMBO PREGNANCY TEST | JHI | Substantially Equivalent | W.H.P.M., Inc. | accessdata.fda.gov |
| August 12, 2004 | K041202 | HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST | KHE | Substantially Equivalent | W.H.P.M., Inc. | accessdata.fda.gov |
| May 20, 2004 | K041273 | ONE-STEP PREGNANCY TEST | LCX | Substantially Equivalent | W.H.P.M., Inc. | accessdata.fda.gov |
| May 19, 2004 | K032575 | FIRST SIGN DRUG OF ABUSE SCREENING TEST | DKZ | Substantially Equivalent | W.H.P.M., Inc. | accessdata.fda.gov |
| June 17, 2003 | K031271 | ONE-STEP PREGNANCY TEST | LCX | Substantially Equivalent | Amerisource Pharmacal, Inc. | accessdata.fda.gov |
| August 28, 2001 | K012284 | WH ACCU TEST PREGNANCY TEST | JHI | Substantially Equivalent | W.H.P.M., Inc. | accessdata.fda.gov |
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Updated June 2, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.