CX(TM) CANNABINOID 50NG(THC5) 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 50ng(thc5) Reagent/synchron Cx Sys.

Pre-market Notification Details

Device IDK944086
510k NumberK944086
Device Name:CX(TM) CANNABINOID 50NG(THC5) REAGENT/SYNCHRON CX SYS
ClassificationEnzyme Immunoassay, Cannabinoids
Applicant BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea,  CA  92622 -8000
ContactSheri Hall
CorrespondentSheri Hall
BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea,  CA  92622 -8000
Product CodeLDJ  
Subsequent Product CodeDLJ
Subsequent Product CodeJJY
CFR Regulation Number862.3870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-07-05
Decision Date1994-12-29

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15099590230500 K944086 000
15099590228743 K944086 000
15099590227258 K944086 000
15099590227234 K944086 000
15099590222956 K944086 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.