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MODIFICATION TO: DIAZYME POTASSIUM ENZYMATIC ASSAY, MODEL DZ113A

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K053566
510(k) Type
Special
Applicant
DIAZYME LABORATORIES
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/15/2006
Days to Decision
55 days
Submission Type
Summary

MODIFICATION TO: DIAZYME POTASSIUM ENZYMATIC ASSAY, MODEL DZ113A

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K053566
510(k) Type
Special
Applicant
DIAZYME LABORATORIES
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/15/2006
Days to Decision
55 days
Submission Type
Summary