ACCESS TESTOSTERONE REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33560, 33565
FDA 510(k) clearance K001935 · decided 2000-08-22
Clearance details
- K-number
- K001935
- Device name
- ACCESS TESTOSTERONE REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33560, 33565
- Applicant
- Beckman Coulter, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-06-26
- Decision date
- 2000-08-22
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- CDZ
- Device class
- 1
- Regulation number
- 862.1680
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Chaska, MN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Beckman Coulter
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
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Access AFP (on DxI 9000 Analyzer) (P980041/S051) | Beckman Coulter, Inc. | 2025-11-03 |
| Access HBsAg, Access HBsAg Confirmatory, Access HBsAg Calibrator, Access HBsAg QC (P230015) | Beckman Coulter, Inc. | 2025-10-17 |
| Access Hybritech p2PSA (P090026/S032) | Beckman Coulter, Inc. | 2025-06-16 |
| Access Hybritech free PSA (P970038/S046) | Beckman Coulter, Inc. | 2025-05-15 |
| Access Hybritech PSA (P850048/S060) | Beckman Coulter, Inc. | 2024-09-04 |
| Access Hybritech PSA reagent pack (P850048/S059) | Beckman Coulter, Inc. | 2023-05-25 |
| Access AFP Reagents on the Access Immunoassay Systems (P980041/S050) | Beckman Coulter, Inc. | 2022-12-16 |
| Access Hybritech PSA Reagents on the Access Immunoassay Systems (P850048/S057) | Beckman Coulter, Inc. | 2022-12-16 |