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510(k) K013118

MODIFICATION TO ALPHA DX SYSTEM by First Medical, Inc. — Product Code JHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 2001
Date Received
September 18, 2001
Clearance Type
Special
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 First Medical, Inc.

  • K014024 — MODIFICATION TO ALPHA DX SYSTEM (December 18, 2001)
  • K010562 — ALPHA DX SYSTEM (March 13, 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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  • K034055 — IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I (January 21, 2004)
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