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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name enzyme immunoassay, cannabinoids
510(k) Number K955677
Device Name SYNCHRON SYSTEMS CANNABINOID 20 NG REAGENT
Applicant
BECKMAN INSTRUMENTS, INC.
200 S. KRAEMER BLVD., W-337
BREA,  CA  92622 -8000
Applicant Contact SHERI HALL
Correspondent
BECKMAN INSTRUMENTS, INC.
200 S. KRAEMER BLVD., W-337
BREA,  CA  92622 -8000
Correspondent Contact SHERI HALL
Regulation Number862.3870
Classification Product Code
LDJ  
Subsequent Product Code
DKB  
Date Received12/15/1995
Decision Date 04/03/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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