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510(k) K890619

EDL ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT by Elite Diagnostic , Ltd. — Product Code GFO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 1989
Date Received
February 7, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Activated Partial Thromboplastin
Device Class
Class II
Regulation Number
864.7925
Review Panel
HE
Submission Type

Other clearances by Elite Diagnostic , Ltd.

  • K891370 — EDL ONE-STAGE PROTHROMBIN TIME REAGENT (April 21, 1989)
  • K890859 — EDL GLOBAL ACTIVATED PARTIAL THROMBOPLASTIN TIME (April 21, 1989)
  • K891175 — EDL ABNORMAL COAGULATION CONTROL (April 10, 1989)
  • K891179 — EDL NORMAL COAGULATION CONTROL (April 10, 1989)

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