VALIDATE D-Dimer Calibration Verification / Linearity Test Kit
FDA 510(k) K170864 · Maine Standards Company, LLC
510(k) numberK170864
Submission
- Device name
- VALIDATE D-Dimer Calibration Verification / Linearity Test Kit
- Applicant
- Maine Standards Company, LLC
Cumberland Foreside, ME, US - Received
- March 23, 2017
- Decision date
- June 21, 2017
- 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 |
|---|---|---|---|
| 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 |
| K142132 | Pool NormGGN · Traditional | Diagnostics Stago S.A.S. | 12/12/2014SE |
| 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 |
More from Diagnostica Stago, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K163498 | VALIDATE Heparin Calibration Verification/Linearity Test KitGGN · Traditional | 03/16/2017SE |
| K162705 | VALIDATE® D-Dimer Calibration Verification/ Linearity Test KitGGN · Traditional | 01/05/2017SE |
| K152961 | VALIDATE D-Dimer Calibration Verification/Linearity Test KitGGN · Traditional | 06/03/2016SE |
| K142964 | VALIDATE Anemia Calibration Verification/ Linearity Test KitJJY · Traditional | 04/30/2015SE |
| K133550 | Validate Ferritin Calibration Verification/ Linearity Test KitJJX · Traditional | 02/05/2014SE |
| K123127 | Validate Psa Calibration Verification/ Linearity Test Kit Model 406JJX · Traditional | 06/14/2013SE |
| K113524 | Validate Vit D Calibration Verification/ Linearity Test KitJJX · Traditional | 01/27/2012SE |
| K110880 | Validate (R) GC3 Calibration Verification / Linearity Test KitJJY · Traditional | 07/05/2011SE |
| K103271 | MSC Lipid ControlJJY · Traditional | 01/25/2011SE |
| K091225 | Validate GC1, GC2, GC3 and GC4 Calibration Verification/Linearity Test SetJJY · Traditional | 06/25/2009SE |
Questions and answers
When was VALIDATE D-Dimer Calibration Verification / Linearity Test Kit cleared by the FDA?
VALIDATE D-Dimer Calibration Verification / Linearity Test Kit (K170864) received a 510(k) decision of Substantially Equivalent on June 21, 2017, 90 days after the submission was received.
What is the product code of K170864?
The FDA product code is GGN – Plasma, Coagulation Control, a Class II (moderate risk) device regulated under 21 CFR 864.5425.