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510(k) K150412

Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator by The Binding Site Group , Ltd. — Product Code DAE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 2015
Date Received
February 18, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Complement C9, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5240
Review Panel
IM
Submission Type

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Other clearances for product code DAE

  • K113349 — HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 CALIBRATOR SET FOR US (July 11, 2012)
  • K992488 — TOTAL HAEMOLYTIC COMPLEMENT RID KIT (September 17, 1999)
  • K974111 — QUIDEL CH50 EQ EIA (July 29, 1998)
  • K954145 — WAKO AUTOKIT CH50 (December 18, 1995)
  • K951639 — COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE) (October 13, 1995)