FIBRINOGEN SCREEN

System, Fibrinogen Determination

PACIFIC HEMOSTASIS

The following data is part of a premarket notification filed by Pacific Hemostasis with the FDA for Fibrinogen Screen.

Pre-market Notification Details

• Device ID: K800826
• 510k Number: K800826
• Device Name: FIBRINOGEN SCREEN
• Classification: System, Fibrinogen Determination
• Applicant: PACIFIC HEMOSTASIS 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: 1980-04-14
• Decision Date: 1980-05-30

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00845275000672	K800826	000