Fastpack Testo Immunoassay
510(k) K101388
Fastpack Testo Immunoassay is a Class I device made by Qualigen Inc., cleared under FDA 510(k) K101388 on 18 Feb 2011, 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 | NumberK101388 | Date18 Feb 2011 | StatusActive |
Official records
- FDA 510(k) database K101388
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- CDZ
- FDA applicant
- Qualigen, Inc.
- Device class
- Class I
- Regulation
- 21 CFR Part 862.1680
- Advisory committee
- Clinical Chemistry
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K101388
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 | |||
|---|---|---|---|---|
| FastPack® IP Testo Kit (30) Testo Immunoassay | 25000041 / Testo Immunoassay | 20816467020031 | — | On the market |
| FastPack® IP Testo Kit (90) Testo Immunoassay | 25000058 / Testo Immunoassay | 30816467020038 | — | On the market |
| FastPack® Testo Kit (50) Testo Immunoassay | 25000009 / Testo Immunoassay | 10816467020034 | — | On the market |
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