ACCESS DHEA-S REAGENT ASSAY
FDA 510(k) clearance K040181 · decided 2004-03-24
Clearance details
- K-number
- K040181
- Device name
- ACCESS DHEA-S REAGENT ASSAY
- Applicant
- Beckman Coulter, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-01-27
- Decision date
- 2004-03-24
- Days to decision
- 57 days
- Clearance type
- Abbreviated
- Product code
- JKC
- Device class
- 1
- Regulation number
- 862.1245
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Brea, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ELECSYS DHEA-S (K003174) | Roche Diagnostics Corp. | 2001-01-17 |
| DHEA-S (K973897) | Kmi Diagnostics, Inc. | 1997-11-13 |
| DSL DHEA-S-7 (K962895) | Diagnostic Systems Laboratories, Inc. | 1996-09-10 |
| DSL AACTIVE DHEA EIA KIT (K955114) | Diagnostic Systems Laboratories, Inc. | 1996-02-23 |
| NICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUNOASSAY (K950524) | Nichols Institute | 1995-05-15 |
| SR1 DHEA-S ENZYME IMMUNOASSAY (K942051) | Serono Diagnostics, Inc. | 1994-07-13 |
| ACTIVE DEHYDROEPIANDROSTERONE (DHEA)(DSL 9000) (K935014) | Diagnostic Systems Laboratories, Inc. | 1994-05-09 |
| IMMULITE DHEA-S04 (K935806) | Diagnostic Products Corp. | 1994-04-26 |
| SYNELISA DHEA-SULFATE (K935469) | Elias U.S.A., Inc. | 1994-03-22 |
| CHEMILUMINESCENCE DHEA-S IMMUNOASSAY (K931601) | Nichols Institute | 1993-07-27 |
| DSL ANDROSTANEDIOL GLUCURONIDE (DSL #6000) (K903616) | Diagnostic Systems Laboratories, Inc. | 1990-09-10 |
| DSL 7900 ACTIVE DHEA-S (DSL #7900) (K891478) | Diagnostic Systems Laboratories, Inc. | 1989-04-26 |
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 |