Sta Liatest Free PS
FDA 510(k) K092170 · Diagnostica Stago, Inc.
510(k) numberK092170
Submission
- Device name
- Sta Liatest Free PS
- Applicant
- Diagnostica Stago, Inc.
Parisppany, NJ, US - Received
- July 21, 2009
- Decision date
- December 22, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GGP – Test, Qualitative And Quantitative Factor Deficiency
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7290
- Specialty
- Hematology
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| K141144 | Sta Liatest D-DiDAP · Traditional | 09/03/2014SE |
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| K092937 | Sta-Hybrid Hep CalibratorJIT · Traditional | 08/02/2010SE |
| K093167 | Sta Compact Automated Multi-Parametric AnalyzerJPA · Special | 12/22/2009SE |
| K093001 | Sta-R Evolution Expert Series Hemostasis System Automated Multi-Parametric AnalyzerJPA · Special | 12/18/2009SE |
| K092113 | Sta - Free PS CalibratorJIX · Traditional | 11/13/2009SE |
Questions and answers
When was Sta Liatest Free PS cleared by the FDA?
Sta Liatest Free PS (K092170) received a 510(k) decision of Substantially Equivalent on December 22, 2009, 154 days after the submission was received.
What is the product code of K092170?
The FDA product code is GGP – Test, Qualitative And Quantitative Factor Deficiency, a Class II (moderate risk) device regulated under 21 CFR 864.7290.