Fastpack Control
510(k) K003095
Fastpack Control is a Class I device made by Qualigen Inc., cleared under FDA 510(k) K003095 on 29 Nov 2000, 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 | NumberK003095 | Date29 Nov 2000 | StatusActive |
Official records
- FDA 510(k) database K003095
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JJX
- FDA applicant
- Qualigen, Inc.
- Device class
- Class I
- Regulation
- 21 CFR Part 862.1660
- Advisory committee
- Clinical Chemistry
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K003095
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 | |||
|---|---|---|---|---|
| Control Kit - PSA PSA Controls | 25000003 / PSA Controls | 00816467020167 | — | On the market |
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