AQUEOUS ETHANOL/AMMONIA CONTROL LEVEL 1, 2, & 3

Multi-analyte Controls, All Kinds (assayed)

CLINICAL CONTROLS, INC.

The following data is part of a premarket notification filed by Clinical Controls, Inc. with the FDA for Aqueous Ethanol/ammonia Control Level 1, 2, & 3.

Pre-market Notification Details

• Device ID: K955690
• 510k Number: K955690
• Device Name: AQUEOUS ETHANOL/AMMONIA CONTROL LEVEL 1, 2, & 3
• Classification: Multi-analyte Controls, All Kinds (assayed)
• Applicant: CLINICAL CONTROLS, INC. 750 FARROLL RD. SUITE B Grover Beach, CA 93433
• Contact: James F Godfrey
• Correspondent: James F Godfrey; CLINICAL CONTROLS, INC. 750 FARROLL RD. SUITE B Grover Beach, CA 93433
• Product Code: JJY
• CFR Regulation Number: 862.1660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-12-14
• Decision Date: 1996-04-24

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00817238010479	K955690	000
00817238010455	K955690	000