510(k) K031759 ยท DKZ Enzyme Immunoassay, Amphetamine
ACON SPECTRUM MULTI-DRUG MULTI-LINE DRUG SCREEN TEST CARD AND ACON SPECTRUM MULTI-DRUG MULTI-LINE DRUG SCREEN TEST CARD
| Applicant | ACON Laboratories, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Aug 4, 2003 |
| Received | Jun 6, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K031759
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 10, 2007 | Bio-Rad Laboratories Inc Bio-Rad-TOX/See Drug Screen Test (25 tests/box), Catalog number 194-5230; Product is distributed by Bio-Rad Laboratories, Inc., Hercules, CA Terminated |
DKZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.