Ethanol-Sl Assay, Catalogue Number 240-12
FDA 510(k) K974002 · Diagnostic Chemicals , Ltd.
510(k) numberK974002
Submission
- Device name
- Ethanol-Sl Assay, Catalogue Number 240-12
- Applicant
- Diagnostic Chemicals , Ltd.
Charlottetown, P.E.I., CA - Received
- October 21, 1997
- Decision date
- April 1, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DIC – Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3040
- Specialty
- Clinical Toxicology
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Questions and answers
When was Ethanol-Sl Assay, Catalogue Number 240-12 cleared by the FDA?
Ethanol-Sl Assay, Catalogue Number 240-12 (K974002) received a 510(k) decision of Substantially Equivalent on April 1, 1998, 162 days after the submission was received.
What is the product code of K974002?
The FDA product code is DIC – Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method, a Class II (moderate risk) device regulated under 21 CFR 862.3040.