VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS

Single (specified) Analyte Controls (assayed And Unassayed)

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 Immunodiagnostic Products Range Verifiers.

Pre-market Notification Details

• Device ID: K974644
• 510k Number: K974644
• Device Name: VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS
• Classification: Single (specified) Analyte Controls (assayed And Unassayed)
• 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: JJX
• CFR Regulation Number: 862.1660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-12-12
• Decision Date: 1998-01-13

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10758750000814	K974644	000
10758750000807	K974644	000
10758750000791	K974644	000
10758750000722	K974644	000