CX(TM) CANNABINOID 100 NG(THC) REAGENT/SYNCHRON CX SYS

Enzyme Immunoassay, Cannabinoids

BECKMAN INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Cx(tm) Cannabinoid 100 Ng(thc) Reagent/synchron Cx Sys.

Pre-market Notification Details

• Device ID: K944088
• 510k Number: K944088
• Device Name: CX(TM) CANNABINOID 100 NG(THC) REAGENT/SYNCHRON CX SYS
• Classification: Enzyme Immunoassay, Cannabinoids
• 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: LDJ
• CFR Regulation Number: 862.3870 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-07-05
• Decision Date: 1994-11-21

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
15099590229801	K944088	000
15099590229559	K944088	000
15099590224868	K944088	000