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

Page Type
Cleared 510(K)
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)
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