Tris Buffered
510(k) K761173
Tris Buffered is a Class II device made by Bio/Data Corp., cleared under FDA 510(k) K761173 on 10 Jan 1977, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK761173 | Date10 Jan 1977 | StatusActive |
Official records
- FDA 510(k) database K761173
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JPA
- Device class
- Class II
- Regulation
- 21 CFR Part 864.5425
- Advisory committee
- Hematology
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code JPA (System, Multipurpose For In Vitro Coagulation Studies).
- Sysmex Automated Blood Coagulation Analyzer CS-5100 by Siemens Healthcare Diagnostic Products GmbH
- Smartcheck Inr System by Inverness Medical Innovations, Inc.
- ACL Coagulation Systems, Models 1000, 2000, 3000, Plus by INSTRUMENTATION LABORATORY COMPANY
- AMAX CS-190 Coagulation Analyzer System by Sigma Diagnostics, Inc.
- IL TEST 84673-30 CHROMOGENICS CONTROL PLASMA by INSTRUMENTATION LABORATORY COMPANY
- Hemochron Verigy System/Factor Vi Qualify System by International Technidyne Corp.
- Coag-A-Mate 2001 by General Diagnostics
- CS-400 Coagulation Analyzer System (A1208) by Sigma Diagnostics, Inc.
- CORA Coagulation Resonance Analysis System by Coramed Technologies, LLC
- Behring Coagulation System, Model BCS by Dade Behring, Inc.