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DIRECT LDL CHOLESTEROL IMMUNOSEPARATION REAGENT KIT

Page Type
Cleared 510(K)
510(k) Number
K943150
510(k) Type
Traditional
Applicant
GENZYME CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/15/1995
Days to Decision
258 days
Submission Type
Summary

DIRECT LDL CHOLESTEROL IMMUNOSEPARATION REAGENT KIT

Page Type
Cleared 510(K)
510(k) Number
K943150
510(k) Type
Traditional
Applicant
GENZYME CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/15/1995
Days to Decision
258 days
Submission Type
Summary