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510(k) K012040

RAMP MYOGLOBIN ASSAY by Response Biomedical Corp. — Product Code DDR

K012040 is an FDA 510(k) premarket notification submitted by Response Biomedical Corp. for the device "RAMP MYOGLOBIN ASSAY". The FDA issued a decision of Substantially Equivalent on December 18, 2001. The device falls under product code DDR (Myoglobin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5680. Response Biomedical Corp. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2001
Date Received
June 29, 2001
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 Response Biomedical Corp.

  • K093116 — MODIFICATION TO: RAMP INFLUENZA A/B ASSAY (October 21, 2009)
  • K091235 — RAMP RSV ASSAY (July 24, 2009)
  • K063662 — RAMP NT-PROBNP ASSAY (July 21, 2008)
  • K071591 — RAMP INFLUENZA A/B ASSAY (April 16, 2008)
  • K033747 — RAMP CK-MB ASSAY (May 17, 2004)
  • K033745 — RAMP TROPONIN I ASSAY (May 17, 2004)

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)

FDA data resources