MAS LIQUID URINALYSIS CONTROL LEVEL 1, LEVEL 2 AND LEVEL 3

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 Mas Liquid Urinalysis Control Level 1, Level 2 And Level 3.

Pre-market Notification Details

• Device ID: K973451
• 510k Number: K973451
• Device Name: MAS LIQUID URINALYSIS CONTROL LEVEL 1, LEVEL 2 AND LEVEL 3
• Classification: Urinalysis Controls (assayed And Unassayed)
• Applicant: MEDICAL ANALYSIS SYSTEMS, INC. 542 FLYNN RD. Camarillo, CA 93012 -8058
• Contact: Scot D Kinghorn
• Correspondent: Scot D Kinghorn; MEDICAL ANALYSIS SYSTEMS, INC. 542 FLYNN RD. Camarillo, CA 93012 -8058
• Product Code: JJW
• CFR Regulation Number: 862.1660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-09-11
• Decision Date: 1997-09-29

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00884883004160	K973451	000
00884883004153	K973451	000
00884883004146	K973451	000
00884883004139	K973451	000