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COBAS-FP REAGENT FOR VALPROIC ACID & CALIBRATORS

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K891581
510(k) Type
Traditional
Applicant
ROCHE DIAGNOSTIC SYSTEMS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/15/1989
Days to Decision
148 days

COBAS-FP REAGENT FOR VALPROIC ACID & CALIBRATORS

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K891581
510(k) Type
Traditional
Applicant
ROCHE DIAGNOSTIC SYSTEMS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/15/1989
Days to Decision
148 days