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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mercuric Thiocyanate, Colorimetry, Chloride
510(k) Number K890015
Device Name BIOTROL CHLORIDE
Applicant
Biotrol, USA, Inc.
113 Branywine Pkwy.
Westchester,  PA  19380
Applicant Contact ALLAN C MURPHY
Correspondent
Biotrol, USA, Inc.
113 Branywine Pkwy.
Westchester,  PA  19380
Correspondent Contact ALLAN C MURPHY
Regulation Number862.1170
Classification Product Code
CHJ  
Date Received01/03/1989
Decision Date 02/17/1989
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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