AMERLITE TBG ASSAY— 510(k) K952284

Substantially Equivalent

Johnson & Johnson Clinical Diagnostics, Inc.

FDA 510(k) clearance K952284 for AMERLITE TBG ASSAY, Substantially Equivalent on 1995-07-26. Applicant: Johnson & Johnson Clinical Diagnostics, Inc..

Clearance details

Applicant: Johnson & Johnson Clinical Diagnostics, Inc.
Product code: Code CEE
Advisory panel: Clinical Chemistry
Date received: 1995-05-16
Decision date: 1995-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

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