Fastpack Calibrators
510(k) K003096
Fastpack Calibrators is a Class II device made by Qualigen Inc., cleared under FDA 510(k) K003096 on 30 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 | NumberK003096 | Date30 Nov 2000 | StatusActive |
Official records
- FDA 510(k) database K003096
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JIT
- FDA applicant
- Qualigen, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 862.1150
- Advisory committee
- Clinical Chemistry
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K003096
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 | |||
|---|---|---|---|---|
| Calibrator Kit - PSA TPSA Cal | 25000002 / TPSA Cal | 00816467020020 | — | On the market |
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Other devices filed under FDA product code JIT (Calibrator, Secondary).
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