URICHEMTRAK LIQUID ASSAYED URINE CONTROL

Urinalysis Controls (assayed And Unassayed)

MEDICAL ANALYSIS SYSTEMS, INC.

The following data is part of a premarket notification filed by Medical Analysis Systems, Inc. with the FDA for Urichemtrak Liquid Assayed Urine Control.

Pre-market Notification Details

• Device ID: K031441
• 510k Number: K031441
• Device Name: URICHEMTRAK LIQUID ASSAYED URINE CONTROL
• Classification: Urinalysis Controls (assayed And Unassayed)
• Applicant: MEDICAL ANALYSIS SYSTEMS, INC. 5300 ADOLFO RD. Camarillo, CA 93012
• Contact: Penny M Layman
• Correspondent: Penny M Layman; MEDICAL ANALYSIS SYSTEMS, INC. 5300 ADOLFO RD. Camarillo, CA 93012
• Product Code: JJW
• CFR Regulation Number: 862.1660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-05-06
• Decision Date: 2003-07-01

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00884883004405	K031441	000
00884883002494	K031441	000
00884883002487	K031441	000
00884883002470	K031441	000