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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stains, Microbiologic
510(k) Number K890020
Device Name ATS LUGOL'S IODINE SOLUTION
Applicant
Alpha-Tec Systems, Inc.
18271 Mcdurmott W., Suite I
Irvine,  CA  92714
Applicant Contact LAURIE A WILLIAMS
Correspondent
Alpha-Tec Systems, Inc.
18271 Mcdurmott W., Suite I
Irvine,  CA  92714
Correspondent Contact LAURIE A WILLIAMS
Regulation Number864.1850
Classification Product Code
JTS  
Date Received01/04/1989
Decision Date 02/24/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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