Tris Buffered Saline

510(k) Number

K761172 ↗

FDA product code

JPA

Device class

Class II

Regulation

21 CFR Part 864.5425

Advisory committee

Hematology

FDA decision

SESE Substantially Equivalent

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code JPA (System, Multipurpose For In Vitro Coagulation Studies).

• ROTEM DELTA THROMBOELASTOMETRY SYSTEM by Pentapharm GmbH
• ROTEM® ap-tem® 503-04-US by Tem Innovations GmbH
• Tris Buffered Saline 100991 by Bio/Data Corporation
• ADDITIONAL HEMOTEC HEPCON/SYS B-10 COAGULATION CAR by Hemotec, Inc.
• ROTEM® ex-tem® 503-05-US by Tem Innovations GmbH
• HEPTRAC ELECTRONIC QUALITY CONTROL by Medtronic Blood Management
• BIOTRACK PROTIME CONTROLS (BIOTRACK PROTIME TEST) by Biotrack, Inc.
• DIGICLOT 2-#820 by Volu Sol Medical Industries
• STA-R EVOLUTION EXPERT SERIES HEMOSTASIS SYSTEM AUTOMATED MULTI-PARAMETRIC ANALYZER by Diagnostica Stago, Incorporated
• Lupus Anticoagulant Confirmation Reagent 102516 by Bio/Data Corporation

• Barbital Saline Buffer

  Class I

  FDA 510(k) K761170 Active Cleared 10 Jan 1977

• Thrombin Clotting Time

  Class II

  FDA 510(k) K811109 Active Cleared 16 Jul 1981

• Arachidonic Acid

  Class II

  FDA 510(k) K811290 Active Cleared 27 Jul 1981

• Beta/Pak

  Class II

  CE/IVDR FDA 510(k) K790769 Active Cleared 3 May 1979 +1authorizations

See all devices from Bio/Data Corp. →