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 IDK761172
510k NumberK761172
Device Name:TRIS BUFFERED SALINE
ClassificationSystem, Multipurpose For In Vitro Coagulation Studies
Applicant BIO/DATA CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJPA  
CFR Regulation Number864.5425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1976-12-01
Decision Date1977-01-10

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
G0561009910 K761172 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.