TRIS BUFFERED SALINE

System, Multipurpose For In Vitro Coagulation Studies

BIO/DATA CORP.

The following data is part of a premarket notification filed by Bio/data Corp. with the FDA for Tris Buffered Saline.

Pre-market Notification Details

• Device ID: K761172
• 510k Number: K761172
• Device Name: TRIS BUFFERED SALINE
• Classification: System, Multipurpose For In Vitro Coagulation Studies
• Applicant: BIO/DATA CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: JPA
• CFR Regulation Number: 864.5425 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1976-12-01
• Decision Date: 1977-01-10

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
G0561009910	K761172	000