Hemochron Control Act Test Tube Normal/Abnor. I/Ii
FDA 510(k) K882481 · International Technidyne Corp.
510(k) numberK882481
Submission
- Device name
- Hemochron Control Act Test Tube Normal/Abnor. I/Ii
- Applicant
- International Technidyne Corp.
Edison, NJ, US - Received
- June 16, 1988
- Decision date
- August 30, 1988
- 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
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|---|---|---|---|
| K170864 | VALIDATE D-Dimer Calibration Verification / Linearity Test KitGGN · Traditional | Maine Standards Company, LLC | 06/21/2017SE |
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| 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 |
|---|---|---|
| K120977 | Directcheck Control for Hemochron Jr. Microcoagulation Systems Act-Lr Cuvette…GGN · Traditional | 07/03/2013SE |
| K050983 | Irma Trupoint Creatinine Control KitJJX · Traditional | 05/16/2005SE |
| K050016 | Hemochron Signature EliteJPA · Traditional | 02/10/2005SE |
| K030818 | Hemochron Response/SystemJPA · Special | 04/02/2003SE |
| K023561 | Itc HGB Pro Professional Hemoglobin Testing SystemGKR · Traditional | 01/31/2003SE |
| K020798 | Hemochron Jr. Signature +JPA · Special | 03/28/2002SE |
| K010599 | Protime Microcoagulation System / Protime 3 CuvetteGJS · Special | 07/02/2001SE |
| K010193 | Hemochron Kaolin-Activated Heparin and Protamine Dosing AssaysKFF · Traditional | 06/06/2001SE |
| K983475 | Hemochron ResponseKQG · Traditional | 05/03/1999SE |
| K990449 | Hemochron Electronic System Verification TubeJPA · Traditional | 04/13/1999SE |
Questions and answers
When was Hemochron Control Act Test Tube Normal/Abnor. I/Ii cleared by the FDA?
Hemochron Control Act Test Tube Normal/Abnor. I/Ii (K882481) received a 510(k) decision of Substantially Equivalent on August 30, 1988, 75 days after the submission was received.
What is the product code of K882481?
The FDA product code is GGN – Plasma, Coagulation Control, a Class II (moderate risk) device regulated under 21 CFR 864.5425.