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VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4 CALIBRATORS (GEM.C005)

Page Type
Cleared 510(K)
510(k) Number
K964721
510(k) Type
Traditional
Applicant
JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/18/1996
Days to Decision
23 days
Submission Type
Statement

VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4 CALIBRATORS (GEM.C005)

Page Type
Cleared 510(K)
510(k) Number
K964721
510(k) Type
Traditional
Applicant
JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/18/1996
Days to Decision
23 days
Submission Type
Statement