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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Urinalysis Controls (Assayed And Unassayed)
510(k) Number K902699
Device Name SHAPE-ACTIO URINALYSIS CONTROLS(ASSAYED & UNASSAY)
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
JJW  
Date Received06/19/1990
Decision Date 07/16/1990
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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