Last synced on 25 January 2026 at 3:41 am

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

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K974839
510(k) Type
Traditional
Applicant
First Medical, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/4/1998
Days to Decision
42 days
Submission Type
Summary

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

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K974839
510(k) Type
Traditional
Applicant
First Medical, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/4/1998
Days to Decision
42 days
Submission Type
Summary