Rocket Reference Plasma, Cat. No. 5188, Modified
FDA 510(k) K911777 · Helena Laboratories
510(k) numberK911777
Submission
- Device name
- Rocket Reference Plasma, Cat. No. 5188, Modified
- Applicant
- Helena Laboratories
Beaumont, TX, US - Received
- April 2, 1991
- Decision date
- August 22, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| 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 |
More from Cliniqa Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K213396 | SPIFE A1AT kitOBZ · Traditional | 10/13/2022SE |
| K192931 | V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo ControlGKA · Traditional | 04/19/2022SE |
| K131479 | V8 SP Normal Control, Abnormal ControlJJY · Traditional | 10/07/2013SE |
| K100103 | Specialty Assayed CONTROL-2GGC · Traditional | 12/15/2010SE |
| K061991 | Plateletworks Arachidonic Acid, Model Pw-AcaGHR · Traditional | 02/23/2007SE |
| K061069 | Spife IFE-15 Pentavalent, Model 3456, Spife IFE-9 Pentavalent Kit, Model 3457, Spift…CFF · Traditional | 07/06/2006SE |
| K061014 | Actalyke QC Kit, Models Aqc-Hp and Aqc-LpJPA · Special | 05/10/2006SE |
| K050053 | Hemoram/Aggram AnalyzerJPA · Traditional | 07/11/2005SE |
| K024162 | Spife 3000 Titan Gel Igg Ief Kit, Model 3389CFF · Traditional | 02/19/2003SE |
| K023761 | Plateletworks, Models Pw-A, Pw-CJOZ · Traditional | 02/14/2003SE |
Questions and answers
When was Rocket Reference Plasma, Cat. No. 5188, Modified cleared by the FDA?
Rocket Reference Plasma, Cat. No. 5188, Modified (K911777) received a 510(k) decision of Substantially Equivalent on August 22, 1991, 142 days after the submission was received.
What is the product code of K911777?
The FDA product code is GGN – Plasma, Coagulation Control, a Class II (moderate risk) device regulated under 21 CFR 864.5425.