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510(k) K020792

ACETAMINOPHEN ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM by Bayer Diagnostics Corp. — Product Code LDP

K020792 is an FDA 510(k) premarket notification submitted by Bayer Diagnostics Corp. for the device "ACETAMINOPHEN ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM". The FDA issued a decision of Substantially Equivalent on July 11, 2002. The device falls under product code LDP (Colorimetry, Acetaminophen), a Class II device regulated under 21 CFR 862.3030. Bayer Diagnostics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 2002
Date Received
March 11, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colorimetry, Acetaminophen
Device Class
Class II
Regulation Number
862.3030
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 LDP

  • K202644 — Acetaminophen (February 18, 2022)
  • K180835 — SEKURE Acetaminophen L3K Assay (February 8, 2019)
  • K110726 — ROCHE ACETAMINOPHEN ASSAY (December 23, 2011)
  • K100200 — ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138 (August 2, 2010)
  • K081938 — ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30 (May 1, 2009)
  • K061655 — DIMENSION VISTA FLEX REAGENT CARTRIDGES (July 10, 2006)
  • K043242 — TRIAGE TOX DRUG SCREEN (February 28, 2005)
  • K042330 — ACETAMINOPHEN-SL ASSAY (January 7, 2005)
  • K013757 — ROCHE ACETAMINOPHEN (January 8, 2002)
  • K011465 — SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PRO (June 8, 2001)

FDA data resources