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510(k) K001286

ETHANOL-L3K ASSAY, MODELS 273-30, 273-17, 273-10 by Diagnostic Chemicals , Ltd. — Product Code DIC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2000
Date Received
April 21, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
Device Class
Class II
Regulation Number
862.3040
Review Panel
TX
Submission Type

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  • K092273 — RANDOX ETHANOL ASSAY (November 1, 2010)
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  • K071811 — ETOH FLEX REAGENT CARTRIDGE (DF22) (August 24, 2007)
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