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510(k) K010562

ALPHA DX SYSTEM by First Medical, Inc. — Product Code MMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 2001
Date Received
February 26, 2001
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 First Medical, Inc.

  • K014024 — MODIFICATION TO ALPHA DX SYSTEM (December 18, 2001)
  • K013118 — MODIFICATION TO ALPHA DX SYSTEM (October 15, 2001)
  • K974839 — ALPHA DX ANALYZER 01-0100, ALPHA DX MYO/CK/CK-MB/TNI CARDIAC PANEL TEST KIT 03-0 (February 4, 1998)

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