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510(k) K010050

ADVIA CENTAUR AND ACS: 180 FOLATE IMMUNOASSAY by Bayer Diagnostics Corp. — Product Code CGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 2001
Date Received
January 5, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acid, Folic, Radioimmunoassay
Device Class
Class II
Regulation Number
862.1295
Review Panel
CH
Submission Type

Other clearances by Bayer Diagnostics Corp.

  • K033379 — BAYER SPECIAL CHEMISTRY CONTROLS (December 19, 2003)
  • K033380 — BAYER SPECIAL CHEMISTRY CALIBRATORS (December 16, 2003)
  • K033007 — BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM (November 14, 2003)
  • K031857 — ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY (September 4, 2003)
  • K022096 — URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (March 18, 2003)
  • K030452 — BAYER LIGAND PLUS 1, 2, 3 CONTROLS (March 3, 2003)
  • K023840 — ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650 (January 7, 2003)
  • K023841 — AMMONIA ASSAY FOR THE ADVIA 1650 (December 24, 2002)
  • K022177 — PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (December 17, 2002)
  • K022329 — CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM (November 27, 2002)

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