CLOTTING FACTOR-VIII-IX-XI-XII DEFICIENT PLASMA

Plasma, Coagulation Factor Deficient

BEHRING DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Clotting Factor-viii-ix-xi-xii Deficient Plasma.

Pre-market Notification Details

• Device ID: K924396
• 510k Number: K924396
• Device Name: CLOTTING FACTOR-VIII-IX-XI-XII DEFICIENT PLASMA
• Classification: Plasma, Coagulation Factor Deficient
• 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: GJT
• CFR Regulation Number: 864.7290 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-08-31
• Decision Date: 1993-05-21

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00842768011023	K924396	000
00842768010996	K924396	000
00842768009990	K924396	000
00842768009976	K924396	000
00842768018831	K924396	000
00842768018862	K924396	000
00842768018824	K924396	000
00842768018879	K924396	000