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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, multipurpose for in vitro coagulation studies
510(k) Number K761176
Device Name CALCIUM CHLORIDE (0.025M)
Applicant
BIO/DATA CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
BIO/DATA CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number864.5425
Classification Product Code
JPA  
Date Received12/01/1976
Decision Date 01/10/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
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