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510(k) K000196

ACCESS MYOGLOBIN ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33310, 33315, 33319, 33316 by Beckman Coulter, Inc. — Product Code DDR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 2000
Date Received
January 21, 2000
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

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Other clearances for product code DDR

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  • 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)