JKC
28 FDA 510(k) clearances · Product code
43 daysmedian time to decision
139 days90th percentile
28clearances measured
FDA profile
- Official device name
- Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1245
- Medical specialty
- Clinical Chemistry
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ACCESS DHEA-S REAGENT ASSAY (K040181) | Beckman Coulter, Inc. | 2004-03-24 |
| 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 |
| DHEA-S RIA KIT (K872879) | Endocrine Associates, Inc. | 1987-10-23 |
| PANTEX DIRECT DHEA-S COATED TUBE RADIOIMMUNOASSAY (K853867) | Pantex, Div. Bio-Analysis, Inc. | 1985-10-04 |
| SOPHEIA DHEA-SO4 EIA KIT (K852847) | Diagnostic Products Corp. | 1985-08-02 |
| ACTIVE DHEA-SULFATE DSL3500 (K851239) | Diagnostic Systems Laboratories, Inc. | 1985-04-25 |
| MATCHED COMPONENT SET FOR RADIOIMMUNO- (K843635) | Cambridge Medical Technology | 1984-09-28 |
| COAT-A-COUNT DHEA-SO4 RIA KIT (K842552) | Diagnostic Products Corp. | 1984-08-17 |
| COAT-A-COUNT DHEA RIA KIT (K842606) | Diagnostic Products Corp. | 1984-08-17 |
| DHEA-S DIRECT RIA KIT (K842555) | Biotecx Laboratories, Inc. | 1984-08-07 |
| DHEA-SULFATE I RIA KIT (K832154) | Diagnostic Systems Laboratories, Inc. | 1983-08-16 |
| 125 I-DEHYDROEPIANDROSTERONE SULFATE (K823200) | Wien Laboratories, Inc. | 1982-11-29 |
| IMMUCHEM COVALENT-COAT (K822140) | Immuchem Corp. | 1982-08-05 |
| I-DHEA-SULFATE RIA KIT 125 (K821145) | Nuclear Medical Systems, Inc. | 1982-05-14 |
| DHEA-SULFATE DIRECT RIA KIT(125I) (K811906) | Immunalysis Corporation | 1981-07-23 |
| DEHYDROEPIANDROSTERONE SULFATE KIT RIA (K802195) | Radioassay Systems Laboratories, Inc. | 1980-10-23 |
| DHEA-SULFATE TEST SET (K792041) | Wien Laboratories, Inc. | 1979-10-30 |
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