Fastpack Total Psa Method Verification Kit
510(k) K062957
Fastpack Total Psa Method Verification Kit is a Class I device made by Qualigen Inc., cleared under FDA 510(k) K062957 on 2 Apr 2007, 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 | NumberK062957 | Date2 Apr 2007 | StatusActive |
Official records
- FDA 510(k) database K062957
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- Withdrawn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 K062957
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 | |||
|---|---|---|---|---|
| Method Verification Kit - PSA TPSA Verifier | 25000017 / TPSA Verifier | 00816467020075 | — | On the market |
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