ROCHE DIAGNOSTICS MAGNESIUM REAGENT, CAT# 1551353

Photometric Method, Magnesium

BOEHRINGER MANNHEIM CORP.

The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Roche Diagnostics Magnesium Reagent, Cat# 1551353.

Pre-market Notification Details

• Device ID: K983416
• 510k Number: K983416
• Device Name: ROCHE DIAGNOSTICS MAGNESIUM REAGENT, CAT# 1551353
• Classification: Photometric Method, Magnesium
• Applicant: BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457
• Contact: Luann Ochs
• Correspondent: Luann Ochs; BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457
• Product Code: JGJ
• CFR Regulation Number: 862.1495 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-09-29
• Decision Date: 1998-10-21
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07613336169438	K983416	000
07613336121412	K983416	000
04015630930821	K983416	000
04015630929818	K983416	000