Roche Elecsys- Acth,Acth Calset,Acth Calcheck,Precicontrol Acth
FDA 510(k) K060585 · Roche Diagnostics Corp.
510(k) numberK060585
Submission
- Device name
- Roche Elecsys- Acth,Acth Calset,Acth Calcheck,Precicontrol Acth
- Applicant
- Roche Diagnostics Corp.
Indianapolis, IN, US - Received
- March 7, 2006
- Decision date
- May 3, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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|---|---|---|---|
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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 |
| 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 |
| K940271 | Incstar Acth IrmaCKG · Traditional | Incstar Corp. | 08/02/1994SE |
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Questions and answers
When was Roche Elecsys- Acth,Acth Calset,Acth Calcheck,Precicontrol Acth cleared by the FDA?
Roche Elecsys- Acth,Acth Calset,Acth Calcheck,Precicontrol Acth (K060585) received a 510(k) decision of Substantially Equivalent on May 3, 2006, 57 days after the submission was received.
What is the product code of K060585?
The FDA product code is CKG – Radioimmunoassay, Acth, a Class II (moderate risk) device regulated under 21 CFR 862.1025.