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510(k) K033747

RAMP CK-MB ASSAY by Response Biomedical Corp. — Product Code JHX

K033747 is an FDA 510(k) premarket notification submitted by Response Biomedical Corp. for the device "RAMP CK-MB ASSAY". The FDA issued a decision of Substantially Equivalent on May 17, 2004. The device falls under product code JHX (Fluorometric Method, Cpk Or Isoenzymes), a Class II device regulated under 21 CFR 862.1215. Response Biomedical Corp. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 2004
Date Received
December 1, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorometric Method, Cpk Or Isoenzymes
Device Class
Class II
Regulation Number
862.1215
Review Panel
CH
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)
  • K033745 — RAMP TROPONIN I ASSAY (May 17, 2004)
  • K012040 — RAMP MYOGLOBIN ASSAY (December 18, 2001)

Other clearances for product code JHX

  • K234005 — Access CK-MB (February 16, 2024)
  • K212648 — VITROS Immunodiagnostic Products CK-MB Reagent Pack (January 28, 2022)
  • K163462 — AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX (September 21, 2017)
  • K120326 — AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKM (November 21, 2012)
  • K081360 — PATHFAST CK-MB-II, PATHFAST MYO-II (August 17, 2009)
  • K051650 — STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS C (September 8, 2005)
  • K041596 — ARCHITECT STAT CK-MB IMMUNOASSAY (July 21, 2004)
  • K034055 — IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I (January 21, 2004)
  • K030012 — CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371 AND (January 17, 2003)
  • K022118 — IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS) (July 22, 2002)

FDA data resources