VITROS IMMUNODDIAGNOSTICS PRODUCTS RE CONTROLS (GEM.5015)— 510(k) K965048

Name: FDA 510(k) clearance K965048
Creator: U.S. Food and Drug Administration
Published: 1997-01-27

Substantially Equivalent

Johnson & Johnson Clinical Diagnostics, Inc.

FDA 510(k) clearance K965048 for VITROS IMMUNODDIAGNOSTICS PRODUCTS RE CONTROLS (GEM.5015), Substantially Equivalent on 1997-01-27. Applicant: Johnson & Johnson Clinical Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Johnson & Johnson Clinical Diagnostics, Inc.
Product code: Code JJY
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 1996-12-18
Decision date: 1997-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

Download summary PDF View on FDA.gov ↗

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