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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 K781635
Device Name CHLORIDE TEST SET, CAT.# 0210
Applicant
STANBIO LABORATORY
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
STANBIO LABORATORY
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1170
Classification Product Code
CHJ  
Date Received09/22/1978
Decision Date 10/03/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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