CGR — Radioimmunoassay, Cortisol Class II
FDA product code CGR covers "Radioimmunoassay, Cortisol", a Class II medical device regulated under 21 CFR 862.1205. 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
- CGR
- Device Class
- Class II
- Regulation Number
- 862.1205
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K242190 | beckman coulter | Access Cortisol; DxC 500i Clinical Analyzer | March 5, 2025 |
| K223038 | beckman coulter | Access Cortisol | February 8, 2023 |
| K202136 | immunodiagnostic systems | IDS Cortisol | April 13, 2021 |
| K203270 | siemens healthcare diagnostics products | IMMULITE/IMMULITE® 1000 Cortisol | January 15, 2021 |
| K202826 | siemens healthcare diagnostics products | IMMULITE® 2000 Cortisol | January 15, 2021 |
| K062626 | ibl-hamburg | CORTISOL ELISA | December 20, 2006 |
| K060480 | ortho-clinical diagnostics | VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND METAB | July 3, 2006 |
| K052359 | lehnus and associates consulting | IBL CORTISOL LIA TEST KIT | October 3, 2005 |
| K050202 | beckman coulter | CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS | February 9, 2005 |
| K042689 | nichols institute diagnostics | NICHOLS ADVANTAGE CORTISOL | December 9, 2004 |
| K010790 | kmi diagnostics | CORTISOL LIA | January 29, 2002 |
| K984520 | nichols institute diagnostics | NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL IMMUNOASSAY, MODEL 62-7005 | February 5, 1999 |
| K983990 | ortho-clinical diagnostics | VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL ASSAY | December 29, 1998 |
| K962208 | nichols institute diagnostics | NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL KIT | April 8, 1997 |
| K954733 | bio-rad laboratories | ACCESS CORTISOL ASSAY (MODIFICATION) | December 5, 1995 |
| K945367 | ciba corning diagnostics | CIBA CORNING ACS CORTISOL IMMUNOASSAY | May 5, 1995 |
| K943427 | schiapparelli biosystems | ACE CEDIA CORTISOL ASSAY | November 28, 1994 |
| K940221 | bio-rad laboratories | ACCESS CORTISOL REAGENTS | April 26, 1994 |
| K931177 | elias u.s.a | SYNELISA CORTISOL | September 27, 1993 |
| K931409 | diagnostic products | IMMULITE CORTISOL | May 11, 1993 |