ST AIA-PACK TESTOSTERONE ASSAY
FDA 510(k) clearance K023091 · decided 2002-12-17
Clearance details
- K-number
- K023091
- Device name
- ST AIA-PACK TESTOSTERONE ASSAY
- Applicant
- Tosoh Medics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-09-17
- Decision date
- 2002-12-17
- Days to decision
- 91 days
- Clearance type
- Traditional
- Product code
- CDZ
- Device class
- 1
- Regulation number
- 862.1680
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- South San Francisco, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Tosoh Medics
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| IDS-iSYS Total Testosterone (K252728) | Immunodiagnostic Systems Limited | 2026-04-15 |
| IDS-iSYS Free Testosterone (K240865) | Immunodiagnostic Systems Limited | 2024-10-23 |
| Access SHBG (K233480) | Beckman Coulter, Inc. | 2024-02-08 |
| Access Testosterone (K223405) | Beckman Coulter, Inc. | 2023-01-13 |
| Elecsys Testosterone II (K211685) | Roche Diagnostics | 2022-05-06 |
| LIAISON Testosterone xt (K201908) | DiaSorin, Inc. | 2020-10-15 |
| ACTIVE® Free Testosterone RIA (K191350) | Immunotech S.R.O. | 2019-12-20 |
| ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG (K191533) | Siemens Healthcare Diagnostics, Inc. | 2019-08-28 |
| IDS SHBG (K190121) | Immunodiagnostic Systems , Ltd. | 2019-06-17 |
| FastPack IP Sex Hormone Binding Globulin Immunoassay (K182521) | Qualigen, Inc. | 2019-01-29 |
| Free Testosterone AccuBind ELISA Test System (K181017) | Monobind, Inc. | 2018-07-20 |
| FREND Testosterone Test System (K153577) | Nanoentek USA, Inc. | 2016-10-14 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of recall (Z-2746-2026) | Tosoh Bioscience Inc | 2026-07-16 |