STAGO FACTOR V-DEFICIENT PLASMA

Plasma, Coagulation Factor Deficient

AMERICAN BIOPRODUCTS CO.

The following data is part of a premarket notification filed by American Bioproducts Co. with the FDA for Stago Factor V-deficient Plasma.

Pre-market Notification Details

• Device ID: K934605
• 510k Number: K934605
• Device Name: STAGO FACTOR V-DEFICIENT PLASMA
• Classification: Plasma, Coagulation Factor Deficient
• Applicant: AMERICAN BIOPRODUCTS CO. 601 NORTH JEFFERSON RD. Parsippany, NJ 07054
• Contact: Andrew Loc B. Le, Ph.d.
• Correspondent: Andrew Loc B. Le, Ph.d.; AMERICAN BIOPRODUCTS CO. 601 NORTH JEFFERSON RD. Parsippany, NJ 07054
• Product Code: GJT
• CFR Regulation Number: 864.7290 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-09-27
• Decision Date: 1994-03-01

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
13607450007449	K934605	000