ALCO-SCREEN

Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method

CHEMATICS, INC.

The following data is part of a premarket notification filed by Chematics, Inc. with the FDA for Alco-screen.

Pre-market Notification Details

• Device ID: K121247
• 510k Number: K121247
• Device Name: ALCO-SCREEN
• Classification: Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
• Applicant: CHEMATICS, INC. P.O. BOX 293 HIGHWAY 13 SOUTH North Webster, IN 46555
• Contact: Carl Reynolds
• Correspondent: Carl Reynolds; CHEMATICS, INC. P.O. BOX 293 HIGHWAY 13 SOUTH North Webster, IN 46555
• Product Code: DIC
• CFR Regulation Number: 862.3040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-04-25
• Decision Date: 2013-03-22
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00737051654806	K121247	000