MEDTOXSCAN

Enzyme Immunoassay, Amphetamine

MEDTOX DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Medtox Diagnostics, Inc. with the FDA for Medtoxscan.

Pre-market Notification Details

• Device ID: K080635
• 510k Number: K080635
• Device Name: MEDTOXSCAN
• Classification: Enzyme Immunoassay, Amphetamine
• Applicant: MEDTOX DIAGNOSTICS, INC. 1238 ANTHONY RD. Burlington, NC 27215
• Contact: Phillip Hartzog
• Correspondent: Phillip Hartzog; MEDTOX DIAGNOSTICS, INC. 1238 ANTHONY RD. Burlington, NC 27215
• Product Code: DKZ
• Subsequent Product Code: DIO
• Subsequent Product Code: DIS
• Subsequent Product Code: DJC
• Subsequent Product Code: DJG
• Subsequent Product Code: DJR
• Subsequent Product Code: JJQ
• Subsequent Product Code: JXM
• Subsequent Product Code: LCM
• Subsequent Product Code: LDJ
• CFR Regulation Number: 862.3100 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-03-06
• Decision Date: 2009-02-13
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00690286000575	K080635	000
10690286000763	K080635	000
00690286000018	K080635	000
10690286000022	K080635	000
10690286000039	K080635	000
00690286000049	K080635	000
10690286000053	K080635	000
00690286000063	K080635	000
00690286000070	K080635	000
00690286000087	K080635	000
00690286000094	K080635	000
00690286000551	K080635	000
00690286000568	K080635	000
10690286000756	K080635	000