Home / 510(k) Clearances / K070640

510(k) K070640

ARCHITECT STAT TROPONIN-1; MYOGLOBIN by Fisher Diagnostics — Product Code MMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 2007
Date Received
March 7, 2007
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Immunoassay Method, Troponin Subunit
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)
  • 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)
  • K041596 — ARCHITECT STAT CK-MB IMMUNOASSAY (July 21, 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 MMI

  • K252393 — VITROS Immunodiagnostic Products hs Troponin I Reagent Pack (October 29, 2025)
  • K243483 — Access hsTnI (August 1, 2025)
  • K242870 — Access hsTnI (June 16, 2025)
  • K240984 — i-STAT hs-TnI cartridge with the i-STAT 1 System (January 3, 2025)
  • K241165 — Atellica® IM High-Sensitivity Troponin I (TnIH) (July 25, 2024)
  • K231974 — PATHFAST®hs-cTnI-II (March 20, 2024)
  • K222881 — Access hsTnI (December 18, 2023)
  • K230648 — Access hsTnI (December 4, 2023)
  • K230994 — Alinity i STAT High Sensitivity Troponin-I (May 4, 2023)
  • K202525 — Alinity i STAT High Sensitivity Troponin-I (May 19, 2022)