CKG — Radioimmunoassay, Acth Class II
FDA product code CKG covers "Radioimmunoassay, Acth", a Class II medical device regulated under 21 CFR 862.1025. 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
- CKG
- Device Class
- Class II
- Regulation Number
- 862.1025
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K223867 | immunodiagnostic systems limited | IDS ACTH II | August 18, 2023 |
| K111335 | tosoh bioscience | ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321 | December 1, 2011 |
| K060585 | roche diagnostics | ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH | May 3, 2006 |
| K050748 | scantibodies laboratory | ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011 | May 20, 2005 |
| K021032 | scantibodies laboratory | ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100 | June 3, 2002 |
| K002638 | future diagnostics | FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT | January 17, 2001 |
| K982608 | sangui biotech | SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KIT | August 19, 1998 |
| K962601 | nichols institute diagnostics | NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONE | December 24, 1996 |
| K960491 | hawksley and sons | MICRO HAEMATOCRIT CENTRIFUGE | October 18, 1996 |
| K960066 | diagnostic products | IMMULITE ACTH | February 16, 1996 |
| K940271 | incstar | INCSTAR ACTH IRMA | August 2, 1994 |
| K926396 | nichols institute | ADRENOCORTICOTROPIC/ACTH ANALYSIS PRODUCT | July 27, 1993 |
| K915727 | mitsubishi yuka america | ACTH IRMA KIT II MITSUBISHI YUKA | March 2, 1992 |
| K910178 | science regulatory services intl | ACTH IRMA KIT MITSUBISHI YUKA | May 22, 1991 |
| K900147 | diagnostic systems laboratories | MODIFIED DSL-2300 ACTH RIA | March 1, 1990 |
| K882741 | nichols institute diagnostics | ALLEGRO ACTH IMMUNOASSAY KIT 65 AND 130 TUBES | August 30, 1988 |
| K860311 | compagnie oris industrie | ACTHK-PR RIA KIT | April 7, 1986 |
| K850053 | euro-diagnostics | BACI 6 -ADRENOCORTICOTROOP HORMONE | April 8, 1985 |
| K850882 | immuno nuclear | ACTH II BY RADIOIMMUNOASSAY | March 21, 1985 |
| K844181 | syncor intl | ACTH RIA | November 27, 1984 |