CX(TM) COCAINE METABOLITE(COCM) REAGENT/SYNCHRON CX SYS

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

BECKMAN INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Cx(tm) Cocaine Metabolite(cocm) Reagent/synchron Cx Sys.

Pre-market Notification Details

• Device ID: K944087
• 510k Number: K944087
• Device Name: CX(TM) COCAINE METABOLITE(COCM) REAGENT/SYNCHRON CX SYS
• Classification: Enzyme Immunoassay, Cocaine And Cocaine Metabolites
• Applicant: BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92622 -8000
• Contact: Sheri Hall
• Correspondent: Sheri Hall; BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92622 -8000
• Product Code: DIO
• CFR Regulation Number: 862.3250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-07-05
• Decision Date: 1994-11-30

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
15099590222048	K944087	000