EMIT 2000 VALPROIC ACID ASSAY, EMIT 2000 VALPROIC ACID CALIBRATORS, MODEL 4G019UL, 4G109UL

Enzyme Immunoassay, Valproic Acid

DADE BEHRING, INC.

The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Emit 2000 Valproic Acid Assay, Emit 2000 Valproic Acid Calibrators, Model 4g019ul, 4g109ul.

Pre-market Notification Details

• Device ID: K002551
• 510k Number: K002551
• Device Name: EMIT 2000 VALPROIC ACID ASSAY, EMIT 2000 VALPROIC ACID CALIBRATORS, MODEL 4G019UL, 4G109UL
• Classification: Enzyme Immunoassay, Valproic Acid
• Applicant: DADE BEHRING, INC. 3403 YERBA BUENA RD. San Jose, CA 95161 -9013
• Contact: Paul L Rogers
• Correspondent: Paul L Rogers; DADE BEHRING, INC. 3403 YERBA BUENA RD. San Jose, CA 95161 -9013
• Product Code: LEG
• CFR Regulation Number: 862.3645 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-08-17
• Decision Date: 2000-10-11

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00630414561950	K002551	000
00842768000959	K002551	000
00842768000942	K002551	000