FDA 510K (K960749) HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT
FDA 510K (K960749) HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT
Device Classification Name Activated Whole Blood Clotting Time
510(k) Number K960749
Device Name HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT
Applicant INTERNATIONAL TECHNIDYNE CORP.
Regulation Number 864.7140
Classification Product Code JBP
Date Received 02/23/1996
Decision Date 08/12/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
Total pages: 357
Fully redacted pages: 249
Content pages: 108
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