510(k) K122904 ยท DKZ Enzyme Immunoassay, Amphetamine
WONDFO MULTI-DRUG URINE TEST CUP MODEL W2002-CU; W2003-CU; W2004-CU; W2005-CU; W2006-CU; W2007-CU; W2008-CU; W2009-CU;
| Applicant | Guangzhou Wondfo Biotech Co., Ltd., Gaithersburg MD, US |
| Decision | Substantially Equivalent, Nov 15, 2012 |
| Received | Sep 21, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K122904
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.