510(k) K032764 ยท DIS Enzyme Immunoassay, Barbiturate
BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT); CAT# 0141 (5000 TESTS KIT)
| Applicant | Lin-Zhi International, Inc., Synnyvale CA, US |
| Decision | Substantially Equivalent, Nov 3, 2003 |
| Received | Sep 5, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032764
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 24, 2012 | Lin-Zhi International Inc Barbiturate Enzyme Immunoassay; R1
Antibody/Substrate Reagent (5000 tests and 500 tests);
Contains a mixture of monoclonal and polyclonal anti-barbiturate antibody, glucose 6-phosphate (G6P) and nicot Terminated |
DIS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.