Enthanol (Rate) Assay, Catalogue No. 219-03
FDA 510(k) K955633 · Diagnostic Chemicals , Ltd.
510(k) numberK955633
Submission
- Device name
- Enthanol (Rate) Assay, Catalogue No. 219-03
- Applicant
- Diagnostic Chemicals , Ltd.
Charlottetown, P.E.I., CA - Received
- December 11, 1995
- Decision date
- May 24, 1996
- 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 Enthanol (Rate) Assay, Catalogue No. 219-03 cleared by the FDA?
Enthanol (Rate) Assay, Catalogue No. 219-03 (K955633) received a 510(k) decision of Substantially Equivalent on May 24, 1996, 165 days after the submission was received.
What is the product code of K955633?
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.