Access Sex Hormone Binding Globulin Reagent, Access Sex Hormone Binding Globulin Calibrators and Access Sex Hormone Bind
FDA 510(k) K083867 · Beckman Coulter, Inc.
510(k) numberK083867
Submission
- Device name
- Access Sex Hormone Binding Globulin Reagent, Access Sex Hormone Binding Globulin Calibrators and Access Sex Hormone Bind
- Applicant
- Beckman Coulter, Inc.
Chaska, MN, US - Received
- December 29, 2008
- Decision date
- August 27, 2009
- 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 |
More from Qualigen, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252169 | Access BNP IINBC · Traditional | 03/24/2026SE |
| K254059 | Access anti-HBc IgMSEI · Traditional | 03/13/2026SE |
| K253687 | Access anti-HBc TotalSEI · Traditional | 02/19/2026SE |
| K251995 | Access anti-HAV IgMLOL · Traditional | 01/27/2026SE |
| K250588 | Access Rubella IgGLFX · Traditional | 11/17/2025SE |
| K252580 | iQ200 SeriesLKM · Special | 09/10/2025SE |
| K243846 | Access anti-HAVLOL · Traditional | 09/09/2025SE |
| K243804 | MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL)…LTT · Traditional | 08/20/2025SE |
| K250036 | MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)LTT · Traditional | 08/15/2025SE |
| K243483 | Access hsTnIMMI · Traditional | 08/01/2025SE |
Questions and answers
When was Access Sex Hormone Binding Globulin Reagent, Access Sex Hormone Binding Globulin Calibrators and Access Sex Hormone Bind cleared by the FDA?
Access Sex Hormone Binding Globulin Reagent, Access Sex Hormone Binding Globulin Calibrators and Access Sex Hormone Bind (K083867) received a 510(k) decision of Substantially Equivalent on August 27, 2009, 241 days after the submission was received.
What is the product code of K083867?
The FDA product code is CDZ – Radioimmunoassay, Testosterones And Dihydrotestosterone, a Class I (low risk) device regulated under 21 CFR 862.1680.