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ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K123322
510(k) Type
Traditional
Applicant
ALFA WASSERMANN DIAGNOSTICS TECHNOLOGIES, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/21/2013
Days to Decision
207 days
Submission Type
Summary

ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K123322
510(k) Type
Traditional
Applicant
ALFA WASSERMANN DIAGNOSTICS TECHNOLOGIES, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/21/2013
Days to Decision
207 days
Submission Type
Summary