MAS LIQUID ASSAYED ALCOHOL/AMMONIA CONTROL LEVEL 1 AND 2

C-reactive Protein, Antigen, Antiserum, And Control

MEDICAL ANALYSIS SYSTEMS, INC.

The following data is part of a premarket notification filed by Medical Analysis Systems, Inc. with the FDA for Mas Liquid Assayed Alcohol/ammonia Control Level 1 And 2.

Pre-market Notification Details

• Device ID: K951057
• 510k Number: K951057
• Device Name: MAS LIQUID ASSAYED ALCOHOL/AMMONIA CONTROL LEVEL 1 AND 2
• Classification: C-reactive Protein, Antigen, Antiserum, And Control
• Applicant: MEDICAL ANALYSIS SYSTEMS, INC. 542 FLYNN RD. Camarillo, CA 93012 -8058
• Contact: Patricia V Willis
• Correspondent: Patricia V Willis; MEDICAL ANALYSIS SYSTEMS, INC. 542 FLYNN RD. Camarillo, CA 93012 -8058
• Product Code: DCK
• CFR Regulation Number: 866.5270 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-03-07
• Decision Date: 1995-04-20

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00884883004467	K951057	000
00884883003811	K951057	000