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HDL CHOLESTEROL REAGENT (PTA/MGCL2)

Page Type
Cleared 510(K)
510(k) Number
K890023
510(k) Type
Traditional
Applicant
SIGMA DIAGNOSTICS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/17/1989
Days to Decision
44 days

HDL CHOLESTEROL REAGENT (PTA/MGCL2)

Page Type
Cleared 510(K)
510(k) Number
K890023
510(k) Type
Traditional
Applicant
SIGMA DIAGNOSTICS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/17/1989
Days to Decision
44 days