Sta- Coag Control (N+Abn) Plus
FDA 510(k) K120014 · Diagnostica Stago, Inc.
510(k) numberK120014
Submission
- Device name
- Sta- Coag Control (N+Abn) Plus
- Applicant
- Diagnostica Stago, Inc.
Parisppany, NJ, US - Received
- December 29, 2011
- Decision date
- March 14, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GGN – Plasma, Coagulation Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5425
- Specialty
- Hematology
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Questions and answers
When was Sta- Coag Control (N+Abn) Plus cleared by the FDA?
Sta- Coag Control (N+Abn) Plus (K120014) received a 510(k) decision of Substantially Equivalent on March 14, 2013, 441 days after the submission was received.
What is the product code of K120014?
The FDA product code is GGN – Plasma, Coagulation Control, a Class II (moderate risk) device regulated under 21 CFR 864.5425.