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VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH CALIBRATORS (GEM.CO55)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K964982
510(k) Type
Traditional
Applicant
JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/20/1997
Days to Decision
70 days
Submission Type
Statement

VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH CALIBRATORS (GEM.CO55)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K964982
510(k) Type
Traditional
Applicant
JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/20/1997
Days to Decision
70 days
Submission Type
Statement