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510(k) K024017

BAYER ADVIA CENTAUR HER-2/NEU ASSAY by Bayer Corp. — Product Code NCW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 2003
Date Received
December 4, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Her-2/Neu, Monitoring
Device Class
Class II
Regulation Number
866.6010
Review Panel
IM
Submission Type

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  • K022288 — COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED (December 17, 2002)
  • K023584 — ASCENSIA DEX 2 DIABETES CARE SYSTEM (November 20, 2002)
  • K020828 — CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM (July 24, 2002)
  • K021428 — CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM (July 5, 2002)
  • K020806 — ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY (March 27, 2002)
  • K013568 — CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (December 21, 2001)
  • K012337 — BAYER ADVIA IMS SYSTEM; C-REACTIVE PROTEIN SYSTEM (December 6, 2001)

Other clearances for product code NCW

  • K994112 — MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA) (September 29, 2000)
  • K992228 — BAYER IMMUNO 1 HER-2/NEU ASSAY (September 29, 2000)