ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION LIQUID DIRECT BILIRUBIN REAGENT, CATALOG NUMBER 1877844

Diazo Colorimetry, Bilirubin

BOEHRINGER MANNHEIM CORP.

The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Roche Diagnostics, Boehringer Mannheim Corporation Liquid Direct Bilirubin Reagent, Catalog Number 1877844.

Pre-market Notification Details

• Device ID: K981883
• 510k Number: K981883
• Device Name: ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION LIQUID DIRECT BILIRUBIN REAGENT, CATALOG NUMBER 1877844
• Classification: Diazo Colorimetry, Bilirubin
• 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: CIG
• CFR Regulation Number: 862.1110 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-05-29
• Decision Date: 1998-07-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04015630999149	K981883	000
04015630991150	K981883	000
04015630991143	K981883	000
04015630991112	K981883	000
04015630928101	K981883	000