BETA/PAK

System, Automated Platelet Aggregation

BIO/DATA CORP.

The following data is part of a premarket notification filed by Bio/data Corp. with the FDA for Beta/pak.

Pre-market Notification Details

• Device ID: K790769
• 510k Number: K790769
• Device Name: BETA/PAK
• Classification: System, Automated Platelet Aggregation
• Applicant: BIO/DATA CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: JOZ
• CFR Regulation Number: 864.5700 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1979-04-19
• Decision Date: 1979-05-03

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
G0561015801	K790769	000
G0561015621	K790769	000
G0561013121	K790769	000
G0561013111	K790769	000
G0561013101	K790769	000
G0561076501	K790769	000