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EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K852391
510(k) Type
Traditional
Applicant
HELENA LABORATORIES
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/1/1985
Days to Decision
118 days

EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K852391
510(k) Type
Traditional
Applicant
HELENA LABORATORIES
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/1/1985
Days to Decision
118 days