Pool Norm
FDA 510(k) K142132 · Diagnostics Stago S.A.S.
510(k) numberK142132
Submission
- Device name
- Pool Norm
- Applicant
- Diagnostics Stago S.A.S.
Gennevilliers, FR - Received
- August 4, 2014
- Decision date
- December 12, 2014
- 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
Other 510(k)s with product code GGN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K170864 | VALIDATE D-Dimer Calibration Verification / Linearity Test KitGGN · Traditional | Maine Standards Company, LLC | 06/21/2017SE |
| K163498 | VALIDATE Heparin Calibration Verification/Linearity Test KitGGN · Traditional | Maine Standards Company, LLC | 03/16/2017SE |
| K161316 | George King Coumadin PlasmaGGN · Traditional | George King Bio-Medical, Inc. | 02/23/2017SE |
| K162705 | VALIDATE® D-Dimer Calibration Verification/ Linearity Test KitGGN · Traditional | Maine Standards Company, LLC | 01/05/2017SE |
| K152961 | VALIDATE D-Dimer Calibration Verification/Linearity Test KitGGN · Traditional | Maine Standards Company, LLC | 06/03/2016SE |
| K150144 | VisuCon-F Low Fibrinogen Control PlasmaGGN · Traditional | Affinity Biologicals, Inc. | 03/06/2016SE |
| K133582 | Hemosil D-Dimer HS 500 ControlGGN · Traditional | Instrumentation Laboratory | 08/15/2014SE |
| K120977 | Directcheck Control for Hemochron Jr. Microcoagulation Systems Act-Lr Cuvette…GGN · Traditional | International Technidyne Corp. | 07/03/2013SE |
| K120900 | I-Stat PT Control Leviel 1 I-Stat PT Control Level 2GGN · Traditional | Cliniqa Corporation | 05/31/2013SE |
| K120014 | Sta- Coag Control (N+Abn) PlusGGN · Traditional | Diagnostica Stago, Inc. | 03/14/2013SE |
Questions and answers
When was Pool Norm cleared by the FDA?
Pool Norm (K142132) received a 510(k) decision of Substantially Equivalent on December 12, 2014, 130 days after the submission was received.
What is the product code of K142132?
The FDA product code is GGN – Plasma, Coagulation Control, a Class II (moderate risk) device regulated under 21 CFR 864.5425.