Emit 2000 Cyclosporine Specific Assay
FDA 510(k) K053061 · Dade Behring, Inc.
510(k) numberK053061
Submission
- Device name
- Emit 2000 Cyclosporine Specific Assay
- Applicant
- Dade Behring, Inc.
Newark, DE, US - Received
- October 31, 2005
- Decision date
- February 6, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MKW – Cyclosporine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1235
- Specialty
- Clinical Chemistry
Other 510(k)s with product code MKW
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|---|---|---|---|
| K080751 | Architect CyclosporineMKW · Traditional | Fujirebio Diagnostics,Inc. | 09/11/2008SE |
| K071455 | Advia Centaur Cyclosporine Assay and CalibratorMKW · Traditional | Siemens Medical Solutions Diagnostics | 09/11/2008SE |
| K081992 | Dimension Vista Csae Flex Regent Cartridge, Model K4108MKW · Special | Siemens Healthcare Diagnostics, Inc. | 08/05/2008SE |
| K062236 | Dimension Vista Cyclosporine (Csa) Flex Reagent CartridgeMKW · Special | Dade Behring, Inc. | 08/21/2006SE |
| K052017 | Cyclosporine Extended Range Assay (Csae) Flex Reagent Cartridge, Catalog # DF108MKW · Traditional | Dade Behring, Inc. | 09/01/2005SE |
| K040761 | Axsym CyclosporineMKW · Traditional | Abbott Laboratories, Inc. | 04/30/2004SE |
| K023208 | Cedia Cyclosporine Plus AssayMKW · Traditional | Microgenics Corp. | 10/24/2002SE |
| K023065 | Cyclosporine (Csa) Flex Reagent CartridgeMKW · Traditional | Dade Behring, Inc. | 10/16/2002SE |
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Questions and answers
When was Emit 2000 Cyclosporine Specific Assay cleared by the FDA?
Emit 2000 Cyclosporine Specific Assay (K053061) received a 510(k) decision of Substantially Equivalent on February 6, 2006, 98 days after the submission was received.
What is the product code of K053061?
The FDA product code is MKW – Cyclosporine, a Class II (moderate risk) device regulated under 21 CFR 862.1235.