OWREN'S VERONAL BUFFER #5375 & FIBRONOGEN KIT#5376

System, Multipurpose For In Vitro Coagulation Studies

HELENA LABORATORIES

The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Owren's Veronal Buffer #5375 & Fibronogen Kit#5376.

Pre-market Notification Details

• Device ID: K926222
• 510k Number: K926222
• Device Name: OWREN'S VERONAL BUFFER #5375 & FIBRONOGEN KIT#5376
• Classification: System, Multipurpose For In Vitro Coagulation Studies
• Applicant: HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont, TX 77704
• Contact: Pat Franks
• Correspondent: Pat Franks; HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 Beaumont, TX 77704
• Product Code: JPA
• CFR Regulation Number: 864.5425 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-12-10
• Decision Date: 1993-02-12

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
M52553750	K926222	000