Panels › Clinical Toxicology › Product code DIC · Class 2
Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
Regulation 862.3040
0510(k)s in 12 months (33 all time)
1recalls in 12 months (7 all time)
6recalls that name a 510(k)
Top companies in DIC
| Company | 510(k)s | Recalls |
|---|---|---|
| Diagnostic Chemicals , Ltd. | 4 | 0 |
| Abbott Laboratories | 3 | 0 |
| Dade Behring, Inc. | 3 | 0 |
| Carolina Liquid Chemistries | 0 | 2 |
| Chematics, Inc. | 2 | 0 |
| E.I. Dupont DE Nemours & Co., Inc. | 2 | 0 |
| Enzymatics C/O Burditt,Bowles,Radzius & Ruberry | 2 | 0 |
| Lin-Zhi International, Inc. | 1 | 1 |
| Abbott Laboratories HPD/ADD/GPRD | 0 | 1 |
| ACON Laboratories, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Alcohol (ALC) Test Saliva Open, Classified |
DIC | None listed |
| Feb 27, 2020 | Siemens Healthcare Diagnostics, Inc. Atellica CH Ethyl Alcohol, Test Code ETOH, Siemens Material Number (SMN) 11097501, UDI 00630414596112. The product is an ethyl alcohol assay, IVD use. Terminated |
DIC | K071811 |
| Jan 16, 2019 | Carolina Liquid Chemistries CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321 Terminated |
DIC | K032461 |
| Jan 16, 2019 | Carolina Liquid Chemistries CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321 Terminated |
DIC | K032461 |
| 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 | K032461 |
| Aug 31, 2011 | Express Diagnostics Int'l., Inc. Drug Check, Distributed by Express Diagnostics Intl Inc., 1550 Industrial Drive, Blue Earth, MN 56013.
Following Cup and Dip product models involved in the recall:
40900
40901
30500-A
30575 -A
3060 Terminated |
DIC | K042975 K050186 +2 |
| Feb 4, 2004 | Abbott Laboratories HPD/ADD/GPRD TDx/TDxFLx REA Ethanol, list 9545-60; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 Terminated |
DIC | K871645 |
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