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510(k) K974839

ALPHA DX ANALYZER 01-0100, ALPHA DX MYO/CK/CK-MB/TNI CARDIAC PANEL TEST KIT 03-0001, ALPHA DX CK/CK-MB PANEL TEST KIT by First Medical, Inc. — Product Code MMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1998
Date Received
December 24, 1997
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 First Medical, Inc.

  • K014024 — MODIFICATION TO ALPHA DX SYSTEM (December 18, 2001)
  • K013118 — MODIFICATION TO ALPHA DX SYSTEM (October 15, 2001)
  • K010562 — ALPHA DX SYSTEM (March 13, 2001)

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  • K231974 — PATHFAST®hs-cTnI-II (March 20, 2024)
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  • 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)