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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single (Specified) Analyte Controls (Assayed And Unassayed)
510(k) Number K885282
Device Name ASSAYED CHOLINESTERASE CONTROL
Applicant
ACTIO, INC.
1127-57TH AVE.
OAKLAND,  CA  94621
Applicant Contact NATHAN LEWIS
Correspondent
ACTIO, INC.
1127-57TH AVE.
OAKLAND,  CA  94621
Correspondent Contact NATHAN LEWIS
Regulation Number862.1660
Classification Product Code
JJX  
Date Received12/20/1988
Decision Date 06/09/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
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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