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ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K123953
510(k) Type
Traditional
Applicant
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/2/2013
Days to Decision
132 days
Submission Type
Summary

ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K123953
510(k) Type
Traditional
Applicant
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/2/2013
Days to Decision
132 days
Submission Type
Summary