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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plasma, Coagulation Control
510(k) Number K834086
Device Name CONTACT-K APTT REAGENT
Applicant
PACIFIC HEMOSTASIS
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
PACIFIC HEMOSTASIS
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number864.5425
Classification Product Code
GGN  
Date Received11/28/1983
Decision Date 02/03/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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