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NANO-CHECK AMI 3 IN 1 CARDIAC DISEASE TEST FOR CARDIAC TROPONIN I, CREATINE KINASE MB AND MYOGLOBIN

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K050975
510(k) Type
Traditional
Applicant
Nano-Ditech Co.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/2/2006
Days to Decision
318 days
Submission Type
Summary

NANO-CHECK AMI 3 IN 1 CARDIAC DISEASE TEST FOR CARDIAC TROPONIN I, CREATINE KINASE MB AND MYOGLOBIN

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K050975
510(k) Type
Traditional
Applicant
Nano-Ditech Co.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/2/2006
Days to Decision
318 days
Submission Type
Summary