FDA 510K (K941007) CATALOG NO. J-ACT+ QC-ACT+
FDA 510K (K941007) CATALOG NO. J-ACT+ QC-ACT+
Device Classification Name Activated Whole Blood Clotting Time
510(k) Number K941007
Device Name CATALOG NO. J-ACT+ & QC-ACT+
Applicant INTERNATIONAL TECHNIDYNE CORP.
Regulation Number 864.7140
Classification Product Code JBP
Date Received 03/01/1994
Decision Date 06/30/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
Total pages: 177
Fully redacted pages: 102
Content pages: 75
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