EMIT II PLUS BARBITUATE ASSAY, MODEL 0SR9D0229

Enzyme Immunoassay, Barbiturate

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 Ii Plus Barbituate Assay, Model 0sr9d0229.

Pre-market Notification Details

• Device ID: K010934
• 510k Number: K010934
• Device Name: EMIT II PLUS BARBITUATE ASSAY, MODEL 0SR9D0229
• Classification: Enzyme Immunoassay, Barbiturate
• 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: DIS
• CFR Regulation Number: 862.3150 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-03-28
• Decision Date: 2001-04-20

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00630414568751	K010934	000
00842768023378	K010934	000