Acth Radioimmunoassay Kit
FDA 510(k) K811565 · Immuno Nuclear Corp.
510(k) numberK811565
Submission
- Device name
- Acth Radioimmunoassay Kit
- Applicant
- Immuno Nuclear Corp.
Mchenry, IL, US - Received
- June 4, 1981
- Decision date
- June 25, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CKG – Radioimmunoassay, Acth
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1025
- Specialty
- Clinical Chemistry
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|---|---|---|---|
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| K111335 | ST Aia-Pack Acth, and ST Aia-Pack Acth Calibrator Set Model 025221 and 025321CKG · Traditional | Tosoh Bioscience, Inc. | 12/01/2011SE |
| K060585 | Roche Elecsys- Acth,Acth Calset,Acth Calcheck,Precicontrol ActhCKG · Traditional | Roche Diagnostics Corp. | 05/03/2006SE |
| K050748 | Acth Immunoradiometric (Irma) Assay Kit, Model 3KG011CKG · Traditional | Scantibodies Laboratory, Inc. | 05/20/2005SE |
| K021032 | Acth Immunoradiometric (Irma) Diagnostic Assay Kit, Model #3KG100CKG · Traditional | Scantibodies Laboratory, Inc. | 06/03/2002SE |
| K002638 | Future Diagnostics B.V. Stat-Acth KitCKG · Traditional | Future Diagnostics B.V. | 01/17/2001SE |
| K982608 | Sangui Biotech, Inc. Acth (Adrenocorticotropic Hormone) Elisa KitCKG · Traditional | Sangui Biotech, Inc. | 08/19/1998SE |
| K962601 | Nichols Advantage Chemiluminescence Adrenocorticotropic HormoneCKG · Traditional | Nichols Institute Diagnostics | 12/24/1996SE |
| K960491 | Micro Haematocrit CentrifugeCKG · Traditional | Hawksley & Sons , Ltd. | 10/18/1996SE |
| K960066 | Immulite ActhCKG · Traditional | Diagnostic Products Corp. | 02/16/1996SE |
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|---|---|---|
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| K863844 | Immuno Biotech's Lamb's Quarters Allergen DiscDHB · Traditional | 10/29/1986SE |
| K863123 | Immuno Biotech Mugwart Allergen DiscDHB · Traditional | 10/01/1986SE |
| K863098 | Meadow Fescue Allergen DiscDHB · Traditional | 09/15/1986SE |
| K862266 | Maple Allergen DiscDHB · Traditional | 08/19/1986SE |
| K862939 | Orchard Grass Allergen DiscDHB · Traditional | 08/15/1986SE |
| K862938 | June Grass Allergen DiscDHB · Traditional | 08/15/1986SE |
| K862265 | Cottonwood Allergen DiscDHB · Traditional | 08/15/1986SE |
| K862176 | Russian Thistle Allergen DiscDHB · Traditional | 08/15/1986SE |
Questions and answers
When was Acth Radioimmunoassay Kit cleared by the FDA?
Acth Radioimmunoassay Kit (K811565) received a 510(k) decision of Substantially Equivalent on June 25, 1981, 21 days after the submission was received.
What is the product code of K811565?
The FDA product code is CKG – Radioimmunoassay, Acth, a Class II (moderate risk) device regulated under 21 CFR 862.1025.