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N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K971573
510(k) Type
Traditional
Applicant
GENZYME CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/18/1997
Days to Decision
49 days
Submission Type
Summary

N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K971573
510(k) Type
Traditional
Applicant
GENZYME CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/18/1997
Days to Decision
49 days
Submission Type
Summary