Activated Partial Thromboplastin Time Test
510(k) K862669
Activated Partial Thromboplastin Time Test is a Class I device made by U.S. Diagnostics Inc., cleared under FDA 510(k) K862669 on 3 Oct 1986, 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 | NumberK862669 | Date3 Oct 1986 | StatusActive |
Official records
- FDA 510(k) database K862669
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GFD
- FDA applicant
- U. S. Diagnostics, Inc.
- Device class
- Class I
- Regulation
- 21 CFR Part 878.4820
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
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