510(k) K032461 ยท DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221
| Applicant | Lin-Zhi International, Inc., Synnyvale CA, US |
| Decision | Substantially Equivalent, Oct 3, 2003 |
| Received | Aug 11, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032461
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 16, 2019 | Carolina Liquid Chemistries CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321 Terminated |
DIC | None listed |
| Jan 16, 2019 | Carolina Liquid Chemistries CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321 Terminated |
DIC | None listed |
| Jan 11, 2019 | Lin-Zhi International Inc Ethyl Alcohol Enzymatic Assay, (a) REF 0220 (small test kit), (b) REF 0221 (large test kit)
Product Usage: Detergent causes faster degradation in EtOH assay. Possible container or pitchers with some Terminated |
DIC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.