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510(k) K020950

SPECTRAL'S 2 IN 1 (TNI-MYO) by Spectral Diagnostics, Inc. — Product Code MMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 2002
Date Received
March 25, 2002
Clearance Type
Traditional
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 Spectral Diagnostics, Inc.

  • K052519 — SPECTRAL WEST NILE VIRUS IGM STATUS TEST (November 30, 2006)
  • DEN030002 — ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE (June 16, 2003)
  • K030057 — SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TEST (March 19, 2003)
  • K022409 — SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST (September 30, 2002)
  • K014105 — SPECTRAL'S TROPONIN I (February 1, 2002)
  • K992127 — CARDIOQUANT TROPONIN I TEST (October 4, 1999)
  • K991447 — CARDIOQUANT CARDIAC ASSESSMENT CONTROLS (June 11, 1999)
  • K982679 — MULTIQUANT (R) QUANTITATIVE MYOGLOBIN TEST (October 7, 1998)
  • K981474 — CARDIAC STATUS CONTROLS (CK-MB/MYOGLOBIN/TROPONIN I) (May 7, 1998)
  • K972687 — CARDIAC STATUS CONTROLS/TROPONIN I (July 28, 1997)

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  • 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)