ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221— 510(k) K032461
Substantially EquivalentLin-Zhi International, Inc.
FDA 510(k) clearance K032461 for ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221, Substantially Equivalent on 2003-10-03. Applicant: Lin-Zhi International, Inc.. Device class: 2.
Clearance details
- Applicant
- Lin-Zhi International, Inc.
- Product code
- Code DIC
- Device class
- Class 2
- Regulation
- 21 CFR 862.3040
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Synnyvale, CA, US
Recent devices under product code DIC
view allMore clearances from Lin-Zhi International, Inc.
view allRecalls naming K032461
K-number listed on FDA's recall record- Z-1252-2019 — CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321
- Z-1253-2019 — CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321
- Z-1256-2019 — 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 detergent residue was used while producing R2 of the defective lot.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K032461.
Data sourced from openFDA. This site is unofficial and independent of the FDA.