FIBRINOGEN CONTROL PLASMA

System, Fibrinogen Determination

AMERICAN DADE

The following data is part of a premarket notification filed by American Dade with the FDA for Fibrinogen Control Plasma.

Pre-market Notification Details

• Device ID: K811069
• 510k Number: K811069
• Device Name: FIBRINOGEN CONTROL PLASMA
• Classification: System, Fibrinogen Determination
• Applicant: AMERICAN DADE 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: KQJ
• CFR Regulation Number: 864.7340 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1981-04-20
• Decision Date: 1981-07-10

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00842768003936	K811069	000
00842768019524	K811069	000