Data / Medical devices / United States / Micro Distributing Ii, Ltd.
Micro Distributing Ii, Ltd.: FDA-registered device maker in Belton, TX, United States, 10 510(k) clearances
Micro Distributing Ii, Ltd. is registered with the FDA (registration 3008416529) in Belton, TX, United States. It lists 12 device types. The FDA files 10 510(k) clearances under its listings, the newest dated August 17, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008416529
- Address
- 620 Kennedy Ct, Belton, TX, United States, 76513
- Owner or operator
- Micro Distributing II, Ltd. (10051894)
- Roles
- Complaint file establishment
- First device listed
- May 17, 2016
- Registered through
- 2026
- Brand names listed
- STAT CASSETTE, STAT CUP, STAT CUPII, STAT DIP, STATCASSETTE, STATCUP, STATCUP II, STATDIP
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 |
|---|---|---|---|---|---|---|
| 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 |
| April 9, 2013 | K130665 | WONDOFO MULTI-DRUG URINE TEST CUP / PANEL | DJG | Substantially Equivalent | Guangzhou Wondfo Biotech Co., Ltd. | accessdata.fda.gov |
| November 15, 2012 | K122904 | WONDFO MULTI-DRUG URINE TEST CUP MODEL W2002-CU; W2003-CU; W2004-CU; W2005-CU; W2006-CU; W2007-CU; W2008-CU; W2009-CU; | DKZ | Substantially Equivalent | Guangzhou Wondfo Biotech Co., Ltd. | accessdata.fda.gov |
| May 8, 2012 | K121166 | WONDFO MULTI-DRUG URINE TEST CUP WONDFO MULTI-DRUG URINE TEST PANEL | DIO | Substantially Equivalent | Guangzhou Wondfo Biotech Co., Ltd. | 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 |
| May 19, 2004 | K032575 | FIRST SIGN DRUG OF ABUSE SCREENING TEST | DKZ | Substantially Equivalent | W.H.P.M., Inc. | accessdata.fda.gov |
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Updated August 17, 2016. 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.