ELECSYS DHEA-S
FDA 510(k) clearance K003174 · decided 2001-01-17
Clearance details
- K-number
- K003174
- Device name
- ELECSYS DHEA-S
- Applicant
- Roche Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2000-10-10
- Decision date
- 2001-01-17
- Days to decision
- 99 days
- Clearance type
- Traditional
- Product code
- JKC
- Device class
- 1
- Regulation number
- 862.1245
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Roche Diagnostics Corp.
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 |
|---|---|---|
| ACCESS DHEA-S REAGENT ASSAY (K040181) | Beckman Coulter, Inc. | 2004-03-24 |
| 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 |
|---|---|---|
| ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECK (P000027/S043) | Roche Diagnostics Corp. | 2025-05-27 |
| ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET (P990056/S044) | Roche Diagnostics Corp. | 2025-05-27 |
| Elecsys Anti-HBc II (P100031/S033) | Roche Diagnostics Corp. | 2025-05-22 |
| Elecsys Anti-HBc II (P100032/S023) | Roche Diagnostics Corp. | 2025-05-22 |
| Elecsys Anti-HBc IgM (P110031/S027) | Roche Diagnostics Corp. | 2025-05-22 |
| Elecsys Anti-HBc IgM (P110022/S034) | Roche Diagnostics Corp. | 2025-05-22 |
| Elecsys Anti-HBs (P010054/S048) | Roche Diagnostics Corp. | 2025-05-22 |
| Elecsys Anti-HBc IgM and PreciControl Anti-HBc IgM (P110031/S025) | Roche Diagnostics Corp. | 2024-11-22 |