Adrenocorticotropic Hormone Test
FDA 510(k) K833934 · Clinetics Corp.
510(k) numberK833934
Submission
- Device name
- Adrenocorticotropic Hormone Test
- Applicant
- Clinetics Corp.
Mchenry, IL, US - Received
- November 14, 1983
- Decision date
- April 4, 1984
- 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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| 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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| 510(k) | Device | Decision |
|---|---|---|
| K862180 | Modified Cotropin Radioimmunoassay KitCEP · Traditional | 07/07/1986SE |
| K844066 | Cotropin Stimulataneous 57 Co-Lh 125I I-FshCGJ · Traditional | 01/18/1985SE |
| K841580 | TSH Receptor Antibody Kit 125I TSHJZO · Traditional | 10/22/1984SE |
| K830357 | Radioimmunoassay Immunoglobulins D.EDGC · Traditional | 03/17/1983SE |
| K823380 | 125-I LH Radioimmunoassay KitCEP · Traditional | 12/22/1982SE |
| K823379 | 125-I FSH Radioimmunoassay KitCGJ · Traditional | 12/22/1982SE |
| K822152 | HCG Beta Ria KitJHI · Traditional | 09/02/1982SE |
| K801306 | Clinetics Pca ColumnDHX · Traditional | 09/26/1980SE |
Questions and answers
When was Adrenocorticotropic Hormone Test cleared by the FDA?
Adrenocorticotropic Hormone Test (K833934) received a 510(k) decision of Substantially Equivalent on April 4, 1984, 142 days after the submission was received.
What is the product code of K833934?
The FDA product code is CKG – Radioimmunoassay, Acth, a Class II (moderate risk) device regulated under 21 CFR 862.1025.