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510(k) K974111

QUIDEL CH50 EQ EIA by Quidel Corp. — Product Code DAE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 1998
Date Received
October 31, 1997
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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  • K131606 — SOFIA INFLUENZA A+B FIA (July 5, 2013)
  • K131619 — QUICKVUE INFLUENZA A+B (June 28, 2013)
  • K122189 — QUIDEL MOLECULAR RSV + HMPV ASSAY (March 8, 2013)
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  • K113777 — QUIDEL MOLECULAR INFLUENZA A+B (March 15, 2012)
  • K112172 — QUIDEL MOLECULAR INFLUENZA A + B ASSAY (December 22, 2011)

Other clearances for product code DAE

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  • K992488 — TOTAL HAEMOLYTIC COMPLEMENT RID KIT (September 17, 1999)
  • K954145 — WAKO AUTOKIT CH50 (December 18, 1995)
  • K951639 — COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE) (October 13, 1995)