VITROS IMMUNODDIAGNOSTICS PRODUCTS RE CONTROLS (GEM.5015)

Multi-analyte Controls, All Kinds (assayed)

JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Johnson & Johnson Clinical Diagnostics, Inc. with the FDA for Vitros Immunoddiagnostics Products Re Controls (gem.5015).

Pre-market Notification Details

• Device ID: K965048
• 510k Number: K965048
• Device Name: VITROS IMMUNODDIAGNOSTICS PRODUCTS RE CONTROLS (GEM.5015)
• Classification: Multi-analyte Controls, All Kinds (assayed)
• Applicant: JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. 100 INDIGO CREEK DR. Rochester, NY 14650 -0882
• Contact: Ann M Quinn
• Correspondent: Ann M Quinn; JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. 100 INDIGO CREEK DR. Rochester, NY 14650 -0882
• Product Code: JJY
• CFR Regulation Number: 862.1660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-12-18
• Decision Date: 1997-01-27

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10758750008322	K965048	000