BEHRING FIBRINTIMER A

System, Multipurpose For In Vitro Coagulation Studies

BEHRING DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Behring Fibrintimer A.

Pre-market Notification Details

• Device ID: K924124
• 510k Number: K924124
• Device Name: BEHRING FIBRINTIMER A
• Classification: System, Multipurpose For In Vitro Coagulation Studies
• Applicant: BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY Somerville, NJ 08876
• Contact: Joseph Kiceina
• Correspondent: Joseph Kiceina; BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY Somerville, NJ 08876
• Product Code: JPA
• CFR Regulation Number: 864.5425 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-08-17
• Decision Date: 1992-12-01

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00842768017742	K924124	000