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ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT

Page Type
Cleared 510(K)
510(k) Number
K113435
510(k) Type
Traditional
Applicant
Alfa Wassermann
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/2/2012
Days to Decision
224 days
Submission Type
Summary

ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT

Page Type
Cleared 510(K)
510(k) Number
K113435
510(k) Type
Traditional
Applicant
Alfa Wassermann
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/2/2012
Days to Decision
224 days
Submission Type
Summary