ROCHE STANDARDS FOR THE COBAS ISE MODULE

Calibrator, Multi-analyte Mixture

ROCHE DIAGNOSTIC SYSTEMS, INC.

The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Roche Standards For The Cobas Ise Module.

Pre-market Notification Details

• Device ID: K897071
• 510k Number: K897071
• Device Name: ROCHE STANDARDS FOR THE COBAS ISE MODULE
• Classification: Calibrator, Multi-analyte Mixture
• Applicant: ROCHE DIAGNOSTIC SYSTEMS, INC. ONE SUNSET AVE. Montclair, NJ 07042
• Contact: Alex Wesolowski
• Correspondent: Alex Wesolowski; ROCHE DIAGNOSTIC SYSTEMS, INC. ONE SUNSET AVE. Montclair, NJ 07042
• Product Code: JIX
• CFR Regulation Number: 862.1150 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1989-12-22
• Decision Date: 1990-03-09

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04015630922741	K897071	000
04015630921003	K897071	000