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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 K870630
Device Name CHLORIDE TEST
Applicant
SCLAVO, INC.
5 MANSARD COURT
WAYNE,  NJ  07470
Applicant Contact DEBRA HOFMEISTER
Correspondent
SCLAVO, INC.
5 MANSARD COURT
WAYNE,  NJ  07470
Correspondent Contact DEBRA HOFMEISTER
Regulation Number862.1170
Classification Product Code
CHJ  
Date Received02/13/1987
Decision Date 04/22/1987
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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