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510(k) K040296

PHOSPHOPLASTIN RL by R2 Diagnostics, Inc. — Product Code GJS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 2004
Date Received
February 9, 2004
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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  • K082631 — THROMBO TEK PSE, MODEL 90-480 (December 17, 2008)
  • K062306 — PLASMACON N, PLASMACON L-1, PLASMACON L-2 (March 16, 2007)
  • K050817 — T-TEK (December 12, 2005)
  • K042919 — FIBROTEK FIB (November 29, 2004)
  • K033471 — PHOSPHOLIN ES AND CALCIUM CHLORIDE (February 4, 2004)

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