MODIFICATION TO SYNCHRON SYSTEMS BENZODIAZEPINE REAGENT


Device Classification Name

enzyme immunoassay, benzodiazipine

510(k) Number K023048
Device Name MODIFICATION TO SYNCHRON SYSTEMS BENZODIAZEPINE REAGENT
Original Applicant
BECKMAN COULTER, INC.
200 south kraemer blvd. w-110
brea, 
CA 
92822

Original Contact annette hellie
Regulation Number 862.3170
Classification Product Code
JXM  
Date Received 09/13/2002
Decision Date 11/07/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No