JKC — Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) Class I
FDA product code JKC covers "Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)", a Class I medical device regulated under 21 CFR 862.1245. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JKC
- Device Class
- Class I
- Regulation Number
- 862.1245
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K040181 | beckman coulter | ACCESS DHEA-S REAGENT ASSAY | March 24, 2004 |
| K003174 | roche diagnostics | ELECSYS DHEA-S | January 17, 2001 |
| K973897 | kmi diagnostics | DHEA-S | November 13, 1997 |
| K962895 | diagnostic systems laboratories | DSL DHEA-S-7 | September 10, 1996 |
| K955114 | diagnostic systems laboratories | DSL AACTIVE DHEA EIA KIT | February 23, 1996 |
| K950524 | nichols institute | NICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUNOASSAY | May 15, 1995 |
| K942051 | serono diagnostics | SR1 DHEA-S ENZYME IMMUNOASSAY | July 13, 1994 |
| K935014 | diagnostic systems laboratories | ACTIVE DEHYDROEPIANDROSTERONE (DHEA)(DSL 9000) | May 9, 1994 |
| K935806 | diagnostic products | IMMULITE DHEA-S04 | April 26, 1994 |
| K935469 | elias u.s.a | SYNELISA DHEA-SULFATE | March 22, 1994 |
| K931601 | nichols institute | CHEMILUMINESCENCE DHEA-S IMMUNOASSAY | July 27, 1993 |
| K903616 | diagnostic systems laboratories | DSL ANDROSTANEDIOL GLUCURONIDE (DSL #6000) | September 10, 1990 |
| K891478 | diagnostic systems laboratories | DSL 7900 ACTIVE DHEA-S (DSL #7900) | April 26, 1989 |
| K872879 | endocrine associates | DHEA-S RIA KIT | October 23, 1987 |
| K853867 | pantex, div. bio-analysis | PANTEX DIRECT DHEA-S COATED TUBE RADIOIMMUNOASSAY | October 4, 1985 |
| K852847 | diagnostic products | SOPHEIA DHEA-SO4 EIA KIT | August 2, 1985 |
| K851239 | diagnostic systems laboratories | ACTIVE DHEA-SULFATE DSL3500 | April 25, 1985 |
| K843635 | cambridge medical technology | MATCHED COMPONENT SET FOR RADIOIMMUNO- | September 28, 1984 |
| K842552 | diagnostic products | COAT-A-COUNT DHEA-SO4 RIA KIT | August 17, 1984 |
| K842606 | diagnostic products | COAT-A-COUNT DHEA RIA KIT | August 17, 1984 |