Gbact + Kit
by Sienco, Inc.
510(k) K984141
Gbact + Kit is a Class II device made by Sienco, Inc., cleared under FDA 510(k) K984141 on 28 May 1999, active as of 11 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 | NumberK984141 | Date28 May 1999 | StatusActive |
Official records
- FDA 510(k) database K984141
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JBP
- Device class
- Class II
- Regulation
- 21 CFR Part 864.7140
- Advisory committee
- Hematology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K984141
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Sonoclot® gbACT+ Kit 800-0411 | 800-0411 / 800-0411 | B55880004111 | — | On the market |
| Sonoclot® gbACT+ Kit 800-0412 | 800-0412 / 800-0412 | B55880004121 | — | On the market |
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