Acth Immunoradiometric (Irma) Diagnostic Assay Kit, Model #3KG100
FDA 510(k) K021032 · Scantibodies Laboratory, Inc.
510(k) numberK021032
Submission
- Device name
- Acth Immunoradiometric (Irma) Diagnostic Assay Kit, Model #3KG100
- Applicant
- Scantibodies Laboratory, Inc.
Santee, CA, US - Received
- March 29, 2002
- Decision date
- June 3, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
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| K962601 | Nichols Advantage Chemiluminescence Adrenocorticotropic HormoneCKG · Traditional | Nichols Institute Diagnostics | 12/24/1996SE |
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More from Incstar Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K060578 | Calcitonin Immunoradiometric Assay (Irma) (Coated Tube Version)JKR · Traditional | 08/30/2006SE |
| K060420 | Modification to Whole PTH (1-84) Specific Immunochemilluminometric (Icma) Assay Kit…CEW · Special | 03/01/2006SE |
| K060348 | Modification to: Total Intact PTH Immunochemiluminometric (Icma) Assay KitCEW · Special | 02/27/2006SE |
| K051888 | Total Intact PTH Immunoradiometric Assay (Coated Tube Version), Model 3KG013CEW · Traditional | 10/18/2005SE |
| K051810 | Whole PTH (1-84) Specific Immunoradiometric Assay (Irma) Coated Tube Kit, Model 3KG014CEW · Traditional | 09/09/2005SE |
| K051150 | Total Intact PTH Immunochemiluminometric (Icma) Assay KitCEW · Traditional | 07/26/2005SE |
| K051141 | Whole PTH (1-84) Specific Immunochemiluminometric Assay (Icma), Model 3KG002CEW · Traditional | 07/26/2005SE |
| K050748 | Acth Immunoradiometric (Irma) Assay Kit, Model 3KG011CKG · Traditional | 05/20/2005SE |
| K031534 | Cyclase Activating PTH (Cap) Immunoradiometric (Irma) Assay Kit, Model 3KG001CEW · Traditional | 07/30/2003SE |
| K004038 | Total PTH Immunoradiometric Assay(Irma) Diagnostic Kit, Model 3KG600CEW · Traditional | 04/30/2001SE |
Questions and answers
When was Acth Immunoradiometric (Irma) Diagnostic Assay Kit, Model #3KG100 cleared by the FDA?
Acth Immunoradiometric (Irma) Diagnostic Assay Kit, Model #3KG100 (K021032) received a 510(k) decision of Substantially Equivalent on June 3, 2002, 66 days after the submission was received.
What is the product code of K021032?
The FDA product code is CKG – Radioimmunoassay, Acth, a Class II (moderate risk) device regulated under 21 CFR 862.1025.