Sta-Cephascreen Kit
FDA 510(k) K053111 · Diagnostica Stago, Inc.
510(k) numberK053111
Submission
- Device name
- Sta-Cephascreen Kit
- Applicant
- Diagnostica Stago, Inc.
Parisppany, NJ, US - Received
- November 4, 2005
- Decision date
- May 4, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GFO – Activated Partial Thromboplastin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7925
- Specialty
- Hematology
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| K092937 | Sta-Hybrid Hep CalibratorJIT · Traditional | 08/02/2010SE |
| K093167 | Sta Compact Automated Multi-Parametric AnalyzerJPA · Special | 12/22/2009SE |
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Questions and answers
When was Sta-Cephascreen Kit cleared by the FDA?
Sta-Cephascreen Kit (K053111) received a 510(k) decision of Substantially Equivalent on May 4, 2006, 181 days after the submission was received.
What is the product code of K053111?
The FDA product code is GFO – Activated Partial Thromboplastin, a Class II (moderate risk) device regulated under 21 CFR 864.7925.