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DIRECT LDL CHOLESTEROL IMMUNOSEPARATION REAGENT KIT

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
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)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
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