BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL

Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl

BOEHRINGER MANNHEIM CORP.

The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Boehringer Mannheim Direct Hdl-cholesterol.

Pre-market Notification Details

• Device ID: K963213
• 510k Number: K963213
• Device Name: BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL
• Classification: Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl
• Applicant: BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. P.O. BOX 50457 Indianapolis, IN 46250 -0457
• Contact: John D Stevens
• Correspondent: John D Stevens; BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. P.O. BOX 50457 Indianapolis, IN 46250 -0457
• Product Code: LBS
• CFR Regulation Number: 862.1475 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-08-16
• Decision Date: 1996-10-23
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04015630926879	K963213	000