EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229

Enzyme Immunoassay, N-acetylprocainamide

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 N-acetylprocainamide Assay, Model Osr4n229.

Pre-market Notification Details

• Device ID: K011620
• 510k Number: K011620
• Device Name: EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229
• Classification: Enzyme Immunoassay, N-acetylprocainamide
• 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: LAN
• CFR Regulation Number: 862.3320 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-05-25
• Decision Date: 2001-06-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00842768023279	K011620	000