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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Automated Platelet Aggregation
510(k) Number K970505
Device Name DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPHRINE TEST CARTRIDGE/PFA COLLAGEN/ADP TEST CARTRIDGE/
Applicant
Dade Intl., Inc.
2173 NW 99th Ave.
Miami,  FL  33172
Applicant Contact BRYAN SCHNEIDER
Correspondent
Dade Intl., Inc.
2173 NW 99th Ave.
Miami,  FL  33172
Correspondent Contact BRYAN SCHNEIDER
Regulation Number864.5700
Classification Product Code
JOZ  
Date Received02/10/1997
Decision Date 11/17/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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