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AMERLITE TBG ASSAY

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K952284
510(k) Type
Traditional
Applicant
JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/26/1995
Days to Decision
71 days
Submission Type
Statement

AMERLITE TBG ASSAY

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K952284
510(k) Type
Traditional
Applicant
JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/26/1995
Days to Decision
71 days
Submission Type
Statement