AST (UV) TEST

Nadh Oxidation/nad Reduction, Ast/sgot

BOEHRINGER MANNHEIM CORP.

The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Ast (uv) Test.

Pre-market Notification Details

• Device ID: K810390
• 510k Number: K810390
• Device Name: AST (UV) TEST
• Classification: Nadh Oxidation/nad Reduction, Ast/sgot
• Applicant: BOEHRINGER MANNHEIM CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: CIT
• CFR Regulation Number: 862.1100 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1981-02-10
• Decision Date: 1981-02-23

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04015630921218	K810390	000
04015630921201	K810390	000
04015630911028	K810390	000