Dimension Vista Lithium Flex Reagent Cartridge
FDA 510(k) K112142 · Siemens Healthcare Diagnostics
510(k) numberK112142
Submission
- Device name
- Dimension Vista Lithium Flex Reagent Cartridge
- Applicant
- Siemens Healthcare Diagnostics
Newark, DE, US - Received
- July 26, 2011
- Decision date
- November 4, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NDW – Assay, Porphyrin, Spectrophotometry, Lithium
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3560
- Specialty
- Clinical Toxicology
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| K050374 | Advia Ims Lithium AssayNDW · Traditional | Bayer Healthcare, LLC | 06/15/2005SE |
| K003583 | Lithium Regent Model TR66056 / Lithium Standard TR66901NDW · Traditional | Trace America, Inc. | 01/17/2001SE |
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Questions and answers
When was Dimension Vista Lithium Flex Reagent Cartridge cleared by the FDA?
Dimension Vista Lithium Flex Reagent Cartridge (K112142) received a 510(k) decision of Substantially Equivalent on November 4, 2011, 101 days after the submission was received.
What is the product code of K112142?
The FDA product code is NDW – Assay, Porphyrin, Spectrophotometry, Lithium, a Class II (moderate risk) device regulated under 21 CFR 862.3560.