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FRUCTOSAMINE TEST (ROCHE)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K854010
510(k) Type
Traditional
Applicant
ROCHE DIAGNOSTIC SYSTEMS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/22/1987
Days to Decision
813 days

FRUCTOSAMINE TEST (ROCHE)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K854010
510(k) Type
Traditional
Applicant
ROCHE DIAGNOSTIC SYSTEMS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/22/1987
Days to Decision
813 days