AMEDITECH IMMUTEST MILTI-DRUG SCREEN

Enzyme Immunoassay, Amphetamine

AMEDITECH, INC.

The following data is part of a premarket notification filed by Ameditech, Inc. with the FDA for Ameditech Immutest Milti-drug Screen.

Pre-market Notification Details

• Device ID: K113046
• 510k Number: K113046
• Device Name: AMEDITECH IMMUTEST MILTI-DRUG SCREEN
• Classification: Enzyme Immunoassay, Amphetamine
• Applicant: AMEDITECH, INC. 10340 CAMINO SANTA FE SUITE F San Diego, CA 92121
• Contact: Greg Cerra
• Correspondent: Greg Cerra; AMEDITECH, INC. 10340 CAMINO SANTA FE SUITE F San Diego, CA 92121
• 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: JXM
• Subsequent Product Code: JXN
• Subsequent Product Code: LAF
• Subsequent Product Code: LCM
• Subsequent Product Code: LDJ
• Subsequent Product Code: LFG
• CFR Regulation Number: 862.3100 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-10-13
• Decision Date: 2011-11-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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