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510(k) K013959

BAYER VALPROIC ACID ASSAY FOR THE ACS:180 AND ADVIA CENTAUR ANALYZERS by Bayer Diagnostics Corp. — Product Code DKB

K013959 is an FDA 510(k) premarket notification submitted by Bayer Diagnostics Corp. for the device "BAYER VALPROIC ACID ASSAY FOR THE ACS:180 AND ADVIA CENTAUR ANALYZERS". The FDA issued a decision of Substantially Equivalent on January 29, 2002. The device falls under product code DKB (Calibrators, Drug Mixture), a Class II device regulated under 21 CFR 862.3200. Bayer Diagnostics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 2002
Date Received
November 30, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrators, Drug Mixture
Device Class
Class II
Regulation Number
862.3200
Review Panel
TX
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)

Other clearances for product code DKB

  • K141928 — COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR (November 25, 2014)
  • K133710 — LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLS (February 21, 2014)
  • K120936 — ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT (December 13, 2012)
  • K092266 — RANDOX METHAMPHETAMINE ASSAY (May 9, 2011)
  • K101752 — THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS (April 8, 2011)
  • K090939 — ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLIN (June 18, 2009)
  • K090900 — ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771 (June 1, 2009)
  • K062162 — DIMENSION VISTA SYSTEM DRUGS OF ABUSE CALIBRATOR (UDAT CAL - KC510) (September 14, 2006)
  • K062121 — DIMENSION VISTA SYSTEM DRUG 2 CALIBRATOR (DRUG 2 CAL - KC420) (August 25, 2006)
  • K060645 — PRECISET DAT PLUS I, PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRAT (May 30, 2006)

FDA data resources