MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q229

Radioimmunoassay, Methaqualone

SYVA CO., DADE BEHRING, INC.

The following data is part of a premarket notification filed by Syva Co., Dade Behring, Inc. with the FDA for Modification To The Emit Ii Plus Methaqualone Assay, Model Osr9q229.

Pre-market Notification Details

• Device ID: K011164
• 510k Number: K011164
• Device Name: MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q229
• Classification: Radioimmunoassay, Methaqualone
• Applicant: SYVA CO., DADE BEHRING, INC. 3403 YERBA BUENA RD. San Jose, CA 95135
• Contact: Cynthia Arredondo
• Correspondent: Cynthia Arredondo; SYVA CO., DADE BEHRING, INC. 3403 YERBA BUENA RD. San Jose, CA 95135
• Product Code: KXS
• CFR Regulation Number: 862.3630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-04-16
• Decision Date: 2001-05-10

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00842768023453	K011164	000