Greiner Minicollect Coagulation Blood Collection Tube
510(k) K992244
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK992244 | Date26 Jul 1999 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JKA
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1675
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 23 Sep 2026
The Greiner Minicollect Coagulation Blood Collection Tube is a tube is a device used for the collection and stabilization of blood specimens for coagulation testing. It contains trisodium citrate at a concentration of 3.2% as an anticoagulant, which binds calcium ions to prevent blood clotting and ensure sample integrity for laboratory analysis.
This tube is supplied as part of the MiniCollect® Capillary Blood Collection system and is designed for use in clinical laboratory settings. It is intended for single-use applications and is compatible with automated instrumentation via 13x75 mm carrier tubes. The device received traditional 510(k) clearance from the FDA under k-number K992244 and product code JKA, with a decision date of July 26, 1999.