Future Diagnostics B.V. Stat-Acth Kit
FDA 510(k) K002638 · Future Diagnostics B.V.
510(k) numberK002638
Submission
- Device name
- Future Diagnostics B.V. Stat-Acth Kit
- Applicant
- Future Diagnostics B.V.
San Diego, CA, US - Received
- August 24, 2000
- Decision date
- January 17, 2001
- 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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|---|---|---|---|
| K223867 | Ids Acth IICKG · Traditional | Immunodiagnostic Systems Limited | 08/18/2023SE |
| 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 |
| 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 |
| K940271 | Incstar Acth IrmaCKG · Traditional | Incstar Corp. | 08/02/1994SE |
More from Incstar Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K000471 | Future Diagnostics B.V. Stat-Intraoperative Intact PTH KitCEW · Traditional | 04/11/2000SE |
Questions and answers
When was Future Diagnostics B.V. Stat-Acth Kit cleared by the FDA?
Future Diagnostics B.V. Stat-Acth Kit (K002638) received a 510(k) decision of Substantially Equivalent on January 17, 2001, 146 days after the submission was received.
What is the product code of K002638?
The FDA product code is CKG – Radioimmunoassay, Acth, a Class II (moderate risk) device regulated under 21 CFR 862.1025.