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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 K852169
Device Name CHLORIDE REAGENT
Applicant
Pointe Scientific, Inc.,
P.O. Box 8569
Detroit,  MI  48224
Applicant Contact JANUSZ M SZYSZKO
Correspondent
Pointe Scientific, Inc.,
P.O. Box 8569
Detroit,  MI  48224
Correspondent Contact JANUSZ M SZYSZKO
Regulation Number862.1170
Classification Product Code
CHJ  
Date Received05/20/1985
Decision Date 08/21/1985
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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