Dimension Vista Integrated System
FDA 510(k) K051087 · Dade Behring, Inc.
510(k) numberK051087
Submission
- Device name
- Dimension Vista Integrated System
- Applicant
- Dade Behring, Inc.
Newark, DE, US - Received
- April 28, 2005
- Decision date
- July 11, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2160
- Specialty
- Clinical Chemistry
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| K071597 | Dimension Vista (R) Afp Flex(R) Reagent Cartridge, Model K6454, Dimension Vista (R) Loci…LOJ · Traditional | 06/04/2008SE |
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| K073055 | Dimension Enzymatic Creatinine Flex Reagent Cartridge with Model DF270JFY · Traditional | 01/03/2008SE |
| K072965 | Dimension Vista C1 in; Flex Reagent Cartridge, Cal, ConDBA · Traditional | 12/21/2007SE |
Questions and answers
When was Dimension Vista Integrated System cleared by the FDA?
Dimension Vista Integrated System (K051087) received a 510(k) decision of Substantially Equivalent on July 11, 2005, 74 days after the submission was received.
What is the product code of K051087?
The FDA product code is JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2160.