EMIT 2000 PROCAINAMIDE ASSAY, MODEL OSR4K229

Enzyme Immunoassay, Procainamide

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 Emit 2000 Procainamide Assay, Model Osr4k229.

Pre-market Notification Details

• Device ID: K010812
• 510k Number: K010812
• Device Name: EMIT 2000 PROCAINAMIDE ASSAY, MODEL OSR4K229
• Classification: Enzyme Immunoassay, Procainamide
• Applicant: SYVA CO., DADE BEHRING, INC. P.O. BOX 49013 3403 YERBA BUENA ROAD San Jose, CA 95135
• Contact: Virginia Singer
• Correspondent: Virginia Singer; SYVA CO., DADE BEHRING, INC. P.O. BOX 49013 3403 YERBA BUENA ROAD San Jose, CA 95135
• Product Code: LAR
• CFR Regulation Number: 862.3320 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-03-19
• Decision Date: 2001-04-13

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00842768023262	K010812	000