Home / 510(k) Clearances / K061008

510(k) K061008

QUICKVUE RSV (20 TEST KIT), MODEL 20193; (2 TEST KIT), MODEL 20199 by Quidel Corp. — Product Code MCE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 2006
Date Received
April 12, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Respiratory Syncytial Virus - Elisa
Device Class
Class I
Regulation Number
866.3480
Review Panel
MI
Submission Type

Other clearances by Quidel Corp.

  • K131813 — QUIDEL MOLECULAR RSV + HMPV ASSAY (September 6, 2013)
  • K131728 — QUIDEL MOLECULAR INFLUENZA A + B ASSAY (August 29, 2013)
  • K130398 — SOFIA(R) RSV FIA (August 13, 2013)
  • K131166 — SOFIA(R) HCG FIA (August 2, 2013)
  • K131606 — SOFIA INFLUENZA A+B FIA (July 5, 2013)
  • K131619 — QUICKVUE INFLUENZA A+B (June 28, 2013)
  • K123998 — QUIDEL MOLECULAR DIRECT C. DIFFICILE ASSAY (March 8, 2013)
  • K122189 — QUIDEL MOLECULAR RSV + HMPV ASSAY (March 8, 2013)
  • K113777 — QUIDEL MOLECULAR INFLUENZA A+B (March 15, 2012)
  • K112172 — QUIDEL MOLECULAR INFLUENZA A + B ASSAY (December 22, 2011)

Other clearances for product code MCE

  • K924289 — KALLESTAD RSV MICROPLATE EIA (February 12, 1993)