TRI-POINT LIQUIMMUNE LIQUID ASSAYED CONTROL LEVELS 1,2, AND 3

Multi-analyte Controls, All Kinds (assayed)

MEDICAL ANALYSIS SYSTEMS, INC.

The following data is part of a premarket notification filed by Medical Analysis Systems, Inc. with the FDA for Tri-point Liquimmune Liquid Assayed Control Levels 1,2, And 3.

Pre-market Notification Details

• Device ID: K011731
• 510k Number: K011731
• Device Name: TRI-POINT LIQUIMMUNE LIQUID ASSAYED CONTROL LEVELS 1,2, AND 3
• Classification: Multi-analyte Controls, All Kinds (assayed)
• Applicant: MEDICAL ANALYSIS SYSTEMS, INC. 5300 ADOLFO RD. Camarillo, CA 93012
• Contact: Darwin Richardson
• Correspondent: Darwin Richardson; MEDICAL ANALYSIS SYSTEMS, INC. 5300 ADOLFO RD. Camarillo, CA 93012
• Product Code: JJY
• CFR Regulation Number: 862.1660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-06-05
• Decision Date: 2001-07-05

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00884883003637	K011731	000
00884883003347	K011731	000
00884883003330	K011731	000
00884883003323	K011731	000
00884883002401	K011731	000
00884883002395	K011731	000
00884883002388	K011731	000
00884883002301	K011731	000