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510(k) K891370

EDL ONE-STAGE PROTHROMBIN TIME REAGENT by Elite Diagnostic , Ltd. — Product Code GJS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1989
Date Received
March 9, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Time, Prothrombin
Device Class
Class II
Regulation Number
864.7750
Review Panel
HE
Submission Type

Other clearances by Elite Diagnostic , Ltd.

  • 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)
  • K890619 — EDL ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT (March 15, 1989)

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