MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229

Enzyme Immunoassay, Theophylline

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 Emit 2000 Theophylline Assay, Model Osr 4p229.

Pre-market Notification Details

• Device ID: K011166
• 510k Number: K011166
• Device Name: MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229
• Classification: Enzyme Immunoassay, Theophylline
• Applicant: SYVA CO., DADE BEHRING, INC. 3403 YERBA BUENA RD. San Jose, CA 95135
• Contact: Virginia Singer
• Correspondent: Virginia Singer; SYVA CO., DADE BEHRING, INC. 3403 YERBA BUENA RD. San Jose, CA 95135
• Product Code: KLS
• CFR Regulation Number: 862.3880 [🔎]
• 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
00842768023286	K011166	000