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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K890442
Device Name SHAPE-ACTIO URINALYSIS CONTROLS
Applicant
Actio, Inc.
1127-57th Ave.
Oakland,  CA  94621
Applicant Contact NATHAN LEWIN
Correspondent
Actio, Inc.
1127-57th Ave.
Oakland,  CA  94621
Correspondent Contact NATHAN LEWIN
Regulation Number862.1660
Classification Product Code
JJY  
Date Received01/27/1989
Decision Date 03/08/1989
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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