FDA Product Code
FDA Product Code CKG — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1025
510(k) Clearances — 30 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K223867 | IDS ACTH II | Immunodiagnostic Systems Limited | 2023-08-18 | Traditional | PDF ↗ |
| K111335 | ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321 | Tosoh Bioscience, Inc. | 2011-12-01 | Traditional | PDF ↗ |
| K060585 | ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH | Roche Diagnostics Corp. | 2006-05-03 | Traditional | PDF ↗ |
| K050748 | ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011 | Scantibodies Laboratory, Inc. | 2005-05-20 | Traditional | PDF ↗ |
| K021032 | ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100 | Scantibodies Laboratory, Inc. | 2002-06-03 | Traditional | PDF ↗ |
| K002638 | FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT | Future Diagnostics B.V. | 2001-01-17 | Traditional | PDF ↗ |
| K982608 | SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KIT | Sangui Biotech, Inc. | 1998-08-19 | Traditional | PDF ↗ |
| K962601 | NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONE | Nichols Institute Diagnostics | 1996-12-24 | Traditional | PDF ↗ |
| K960491 | MICRO HAEMATOCRIT CENTRIFUGE | Hawksley & Sons , Ltd. | 1996-10-18 | Traditional | PDF ↗ |
| K960066 | IMMULITE ACTH | Diagnostic Products Corp. | 1996-02-16 | Traditional | PDF ↗ |
| K940271 | INCSTAR ACTH IRMA | Incstar Corp. | 1994-08-02 | Traditional | PDF ↗ |
| K926396 | ADRENOCORTICOTROPIC/ACTH ANALYSIS PRODUCT | Nichols Institute | 1993-07-27 | Traditional | PDF ↗ |
| K915727 | ACTH IRMA KIT II MITSUBISHI YUKA | Mitsubishi Yuka America, Inc. | 1992-03-02 | Traditional | PDF ↗ |
| K910178 | ACTH IRMA KIT MITSUBISHI YUKA | Science Regulatory Services Intl. | 1991-05-22 | Traditional | PDF ↗ |
| K900147 | MODIFIED DSL-2300 ACTH RIA | Diagnostic Systems Laboratories, Inc. | 1990-03-01 | Traditional | PDF ↗ |
| K882741 | ALLEGRO ACTH IMMUNOASSAY KIT 65 AND 130 TUBES | Nichols Institute Diagnostics | 1988-08-30 | Traditional | PDF ↗ |
| K860311 | ACTHK-PR RIA KIT | Compagnie Oris Industrie, S.A. | 1986-04-07 | Traditional | PDF ↗ |
| K850053 | BACI 6 -ADRENOCORTICOTROOP HORMONE | Euro-Diagnostics BV | 1985-04-08 | Traditional | PDF ↗ |
| K850882 | ACTH II BY RADIOIMMUNOASSAY | Immuno Nuclear Corp. | 1985-03-21 | Traditional | PDF ↗ |
| K844181 | ACTH RIA | Syncor Intl. Corp. | 1984-11-27 | Traditional | PDF ↗ |
| K842249 | ACTH NORMAL RANGE | Diagnostic Systems Laboratories, Inc. | 1984-08-15 | Traditional | PDF ↗ |
| K833934 | ADRENOCORTICOTROPIC HORMONE TEST | Clinetics Corp. | 1984-04-04 | Traditional | PDF ↗ |
| K840018 | DPC ACTH KIT | Diagnostic Products Corp. | 1984-03-23 | Traditional | PDF ↗ |
| K833849 | ACTH RIA | Syncor Intl. Corp. | 1984-01-30 | Traditional | PDF ↗ |
| K833471 | ADRENOCOR TICOTROPIC HORMONE RADIOIMM | Nichols Institute Diagnostics | 1984-01-11 | Traditional | PDF ↗ |
| K831855 | HATCH KIT | Radioassay Systems Laboratories, Inc. | 1983-07-28 | Traditional | PDF ↗ |
| K831826 | ADRENOCORTICOTROPIN RADIO-IMMUNOASSAY | Damon Corp. | 1983-07-18 | Traditional | PDF ↗ |
| K830893 | ACTH RIA SYSTEM-DSI 2300 | Diagnostic Systems Laboratories, Inc. | 1983-04-27 | Traditional | PDF ↗ |
| K822115 | SERAGAN ACTH125 I-RIA KIT | Seragen Diagnostics, Inc. | 1982-10-18 | Traditional | PDF ↗ |
| K811565 | ACTH RADIOIMMUNOASSAY KIT | Immuno Nuclear Corp. | 1981-06-25 | Traditional | PDF ↗ |
Product code CKG · Class II · Clinical Chemistry. Data: openFDA.