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CLINISTAT HDL CHOLESTEROL REAGENT TEST

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K895139
510(k) Type
Traditional
Applicant
HERAEUS KULZER, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/27/1989
Days to Decision
133 days

CLINISTAT HDL CHOLESTEROL REAGENT TEST

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K895139
510(k) Type
Traditional
Applicant
HERAEUS KULZER, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/27/1989
Days to Decision
133 days