FDA 510K (K014008) HEMOCHRON JR. CITRATE APTT CUVETTE
FDA 510K (K014008) HEMOCHRON JR. CITRATE APTT CUVETTE
Device Classification Name Activated Partial Thromboplastin
510(k) Number K014008
Device Name HEMOCHRON JR. CITRATE APTT CUVETTE
Applicant ITC, INC.
Regulation Number 864.7925
Classification Product Code GFO
Date Received 12/05/2001
Decision Date 01/24/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
Total pages: 86
Fully redacted pages: 5
Content pages: 81
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