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COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT

Page Type
Cleared 510(K)
510(k) Number
K982848
510(k) Type
Traditional
Applicant
ROCHE DIAGNOSTIC SYSTEMS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/1/1998
Days to Decision
50 days
Submission Type
Summary

COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT

Page Type
Cleared 510(K)
510(k) Number
K982848
510(k) Type
Traditional
Applicant
ROCHE DIAGNOSTIC SYSTEMS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/1/1998
Days to Decision
50 days
Submission Type
Summary