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510(k) K041596

ARCHITECT STAT CK-MB IMMUNOASSAY by Fisher Diagnostics — Product Code JHX

K041596 is an FDA 510(k) premarket notification submitted by Fisher Diagnostics for the device "ARCHITECT STAT CK-MB IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on July 21, 2004. The device falls under product code JHX (Fluorometric Method, Cpk Or Isoenzymes), a Class II device regulated under 21 CFR 862.1215. Fisher Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 2004
Date Received
June 14, 2004
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 Fisher Diagnostics

  • K170652 — ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R (June 1, 2017)
  • K070640 — ARCHITECT STAT TROPONIN-1; MYOGLOBIN (September 13, 2007)
  • K052407 — ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS (July 18, 2006)
  • K052308 — ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY C (May 10, 2006)
  • K042924 — ARCHITECT STAT MYO IMMUNOASSAY (January 24, 2005)
  • K041192 — ARCHITECT STAT TROPONIN-I IMMUNOASSAY (August 12, 2004)
  • K023362 — FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLU (December 9, 2002)
  • K013397 — PACIFIC HEMOSTASIS REFERENCE EMULSION (February 15, 2002)
  • K010750 — PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560 (September 7, 2001)
  • K850160 — FISHER DIAGNOSTICS LATEST-CRP TEST KIT (April 19, 1985)

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)
  • K033747 — RAMP CK-MB ASSAY (May 17, 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