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VITROS IMMUNODIAGNOSTICS PRODUCT - TOTAL T3 REAGENT PACK (GEM .101) AND TOTAL CALIIBRATION (GEM.C010)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K964310
510(k) Type
Traditional
Applicant
JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/27/1996
Days to Decision
29 days
Submission Type
Statement

VITROS IMMUNODIAGNOSTICS PRODUCT - TOTAL T3 REAGENT PACK (GEM .101) AND TOTAL CALIIBRATION (GEM.C010)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K964310
510(k) Type
Traditional
Applicant
JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/27/1996
Days to Decision
29 days
Submission Type
Statement