Last synced on 30 May 2025 at 11:05 pm

N-GENEOUS LDL-ST CHOLESTEROL REAGENT, N-GENEOUS LDL-ST 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
K992766
510(k) Type
Traditional
Applicant
GENZYME CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/18/1999
Days to Decision
62 days
Submission Type
Summary

N-GENEOUS LDL-ST CHOLESTEROL REAGENT, N-GENEOUS LDL-ST 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
K992766
510(k) Type
Traditional
Applicant
GENZYME CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/18/1999
Days to Decision
62 days
Submission Type
Summary