Architect SHBG Reagent Kit, Architect SHBG Calibrator Kit, and Architect SHBG Control Kit with Models, 8K26-25, 8K26-01
FDA 510(k) K060818 · Biokit, S.A.
510(k) numberK060818
Submission
- Device name
- Architect SHBG Reagent Kit, Architect SHBG Calibrator Kit, and Architect SHBG Control Kit with Models, 8K26-25, 8K26-01
- Applicant
- Biokit, S.A.
Barcelona, ES - Received
- March 27, 2006
- Decision date
- January 23, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CDZ – Radioimmunoassay, Testosterones And Dihydrotestosterone
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1680
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CDZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252728 | IDS-iSYS Total TestosteroneCDZ · Traditional | Immunodiagnostic Systems Limited | 04/15/2026SE |
| K240865 | IDS-iSYS Free TestosteroneCDZ · Traditional | Immunodiagnostic Systems Limited | 10/23/2024SE |
| K233480 | Access SHBGCDZ · Traditional | Beckman Coulter, Inc. | 02/08/2024SE |
| K223405 | Access TestosteroneCDZ · Traditional | Beckman Coulter, Inc. | 01/13/2023SE |
| K211685 | Elecsys Testosterone IICDZ · Traditional | Roche Diagnostics | 05/06/2022SE |
| K201908 | LIAISON Testosterone xtCDZ · Special | DiaSorin, Inc. | 10/15/2020SE |
| K191350 | ACTIVE® Free Testosterone RIACDZ · Special | Immunotech S.R.O. | 12/20/2019SE |
| K191533 | ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBGCDZ · Traditional | Siemens Healthcare Diagnostics, Inc. | 08/28/2019SE |
| K190121 | Ids SHBGCDZ · Traditional | Immunodiagnostic Systems , Ltd. | 06/17/2019SE |
| K182521 | FastPack IP Sex Hormone Binding Globulin ImmunoassayCDZ · Traditional | Qualigen, Inc. | 01/29/2019SE |
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| K214068 | Quantia IgEDGC · Special | 02/21/2023SE |
| K181334 | ADVIA Centaur Herpes-2 IgGMYF · Traditional | 08/23/2018SE |
| K181333 | ADVIA Centaur Herpes-1 IgGMXJ · Traditional | 08/23/2018SE |
| K152185 | Architect SHBGCDZ · Traditional | 02/11/2016SE |
| K132400 | Lp(A) Calibrators, and Lp(A) ControlsJIT · Abbreviated | 12/19/2013SE |
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Questions and answers
When was Architect SHBG Reagent Kit, Architect SHBG Calibrator Kit, and Architect SHBG Control Kit with Models, 8K26-25, 8K26-01 cleared by the FDA?
Architect SHBG Reagent Kit, Architect SHBG Calibrator Kit, and Architect SHBG Control Kit with Models, 8K26-25, 8K26-01 (K060818) received a 510(k) decision of Substantially Equivalent on January 23, 2007, 302 days after the submission was received.
What is the product code of K060818?
The FDA product code is CDZ – Radioimmunoassay, Testosterones And Dihydrotestosterone, a Class I (low risk) device regulated under 21 CFR 862.1680.