EMIT II PLUS ETHYL ALCOHOL ASSAY, MODEL OSR9K229

Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method

SYVA CO., DADE BEHRING, INC.

The following data is part of a premarket notification filed by Syva Co., Dade Behring, Inc. with the FDA for Emit Ii Plus Ethyl Alcohol Assay, Model Osr9k229.

Pre-market Notification Details

• Device ID: K010960
• 510k Number: K010960
• Device Name: EMIT II PLUS ETHYL ALCOHOL ASSAY, MODEL OSR9K229
• Classification: Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
• Applicant: SYVA CO., DADE BEHRING, INC. P.O. BOX 49013 3403 YERBA BUENA ROAD San Jose, CA 95135
• Contact: Susan Collins
• Correspondent: Susan Collins; SYVA CO., DADE BEHRING, INC. P.O. BOX 49013 3403 YERBA BUENA ROAD San Jose, CA 95135
• Product Code: DIC
• CFR Regulation Number: 862.3040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-03-30
• Decision Date: 2001-04-26

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00842768023439	K010960	000