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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimetry, Cholinesterase
510(k) Number K893583
Device Name BECKMAN CHOLINESTERASE REAGENT KIT
Applicant
Beckman
200 S. Kraemer Blvd.
W-337
Brea,  CA  92621
Applicant Contact WILLIAM T RYAN
Correspondent
Beckman
200 S. Kraemer Blvd.
W-337
Brea,  CA  92621
Correspondent Contact WILLIAM T RYAN
Regulation Number862.3240
Classification Product Code
DIH  
Date Received05/09/1989
Decision Date 08/15/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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