ENXYMATIC CREATININE TEST

Enzymatic Method, Creatinine

BOEHRINGER MANNHEIM CORP.

The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Enxymatic Creatinine Test.

Pre-market Notification Details

• Device ID: K812095
• 510k Number: K812095
• Device Name: ENXYMATIC CREATININE TEST
• Classification: Enzymatic Method, Creatinine
• Applicant: BOEHRINGER MANNHEIM CORP. 4221 Richmond Rd., N.W. Walker, MI 49534
• Product Code: JFY
• CFR Regulation Number: 862.1225 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1981-07-24
• Decision Date: 1981-08-31

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04015630916221	K812095	000
04015630906789	K812095	000