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510(k) K981012

AIA-PACK MYOGLOBIN ASSAY by Tosoh Medics, Inc. — Product Code DDR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 1998
Date Received
March 18, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Myoglobin, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5680
Review Panel
IM
Submission Type

Other clearances by Tosoh Medics, Inc.

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  • K023091 — ST AIA-PACK TESTOSTERONE ASSAY (December 17, 2002)
  • K023891 — ST AIA-PACK CA 125 ENZYME IMMUNOASSAY (December 6, 2002)
  • K020489 — G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE (May 14, 2002)
  • K012820 — AIA-PACK CTNI 2ND-GEN ASSAY (December 14, 2001)
  • K011434 — G7 AUTOMATED HPLC ANALYZER (September 18, 2001)
  • K010796 — AIA-PACK BRCA, ST AIA PACK BRCA (August 16, 2001)
  • K992365 — AIA-PACK FOLATE ASSAY (August 10, 1999)
  • K990431 — AIA-PACK CA 125 (June 3, 1999)

Other clearances for product code DDR

  • K231832 — Access Myoglobin (September 18, 2023)
  • K123785 — DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET (June 7, 2013)
  • K122599 — ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR (October 3, 2012)
  • K083260 — ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN (October 16, 2009)
  • K080481 — ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CA (February 20, 2009)
  • K061683 — TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM (July 21, 2006)
  • K042924 — ARCHITECT STAT MYO IMMUNOASSAY (January 24, 2005)
  • K042982 — QUANTEX MYOGLOBIN (December 22, 2004)
  • K033300 — VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; CALIBRATORS; RANGE VERI (November 5, 2003)
  • K021229 — MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973 (June 28, 2002)