Thromboplastin.Fs
by American Dade 510(k)
Active
510(k) K864272
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK864272 | Date13 Nov 1986 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
Overview
AI-generated summary, 21 Sep 2026
Thromboplastin.Fs is a test, time, prothrombin device used for in vitro coagulation studies. It is classified as a Class II medical device under product code GJS and regulation number 864.7750.
The device was cleared by the FDA through the traditional 510(k) pathway on November 13, 1986, under K864272, and is substantially equivalent to a predicate device. It is manufactured by American Dade in Santa Ana, California.
Other devices from American Dade
Questions
AI-generated answers, 21 Sep 2026
What is THROMBOPLASTIN.FS used for?
THROMBOPLASTIN.FS is used for in vitro coagulation studies, specifically as a test, time, prothrombin device to measure prothrombin time in laboratory settings.
How is THROMBOPLASTIN.FS supplied and is it sterile or single-use?
The device data does not specify supply format, sterility, or single-use/reuse status; these details are not included in the provided authorization or specifications.
What regulatory pathway was used for THROMBOPLASTIN.FS and when was it cleared?
THROMBOPLASTIN.FS was cleared by the FDA through the traditional 510(k) pathway on November 13, 1986, under submission K864272, and found substantially equivalent to a predicate device.