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510(k) K092987

INRATIO/INRATIO2 TEST STRIPS by Biosite Incorporated — Product Code GJS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 2010
Date Received
September 28, 2009
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

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  • K062840 — TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS (March 1, 2007)
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  • K060788 — TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414 (July 10, 2006)
  • K060791 — TRIAGE TOX DRUG SCREEN, MODEL 94400 (June 22, 2006)
  • K052789 — TRIAGE BNP TEST FOR BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL 98200 (January 23, 2006)
  • K051787 — TRIAGE BNP TEST, MODEL 98000XR (September 22, 2005)

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