Simplastin L
by Organon Teknika Corp. 510(k)
Active
510(k) K915746
Overview
Simplastin L is a prothrombin time test device used in hematology. It is designed to assist in the assessment of blood coagulation pathways.
This device has received FDA 510(k) clearance under K915746. It is manufactured by Organon Teknika Corp. and is classified under regulation number 864.7750.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK915746 | Date12 Feb 1992 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- GJS
- Device Class
- Class II
- Regulation
- 21 CFR Part 864.7750
- Advisory Committee
- Hematology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Organon Teknika Corp.
Questions
What is the primary use of Simplastin L?
Simplastin L is a hematology device specifically designed to assist clinicians in the assessment of blood coagulation pathways by performing prothrombin time tests.
What is the regulatory status of this device?
Simplastin L has received FDA 510(k) clearance under K915746. This indicates that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices.
Which medical specialty is this device associated with?
This device is classified under the hematology medical specialty, specifically falling under regulation number 864.7750, which pertains to prothrombin time test systems.