Hemochron Response
FDA 510(k) K983475 · International Technidyne Corp.
510(k) numberK983475
Submission
- Device name
- Hemochron Response
- Applicant
- International Technidyne Corp.
Edison, NJ, US - Received
- October 2, 1998
- Decision date
- May 3, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KQG – Instrument, Coagulation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5400
- Specialty
- Hematology
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K050821 | Coagcare Anticoagulation Management SystemKQG · Traditional | Zycare | 08/16/2005SE |
| K021976 | FIBRON-1, FIBRON-4, Quikcoag, FibronKQG · Traditional | Vital Scientific N.V. | 10/25/2002SE |
| K992130 | Pacific Hemostasis Thromboscreen 400CKQG · Traditional | Pacific Hemostasis | 09/03/1999SE |
| K991321 | Pacific Hemostasis Thromboscreen 200KQG · Traditional | Pacific Hemostasis | 06/21/1999SE |
| K902614 | Elvi 828 Digiclot MultiscanKQG · Traditional | Logos Scientific, Inc. | 11/08/1990SE |
| K900685 | Clot 2 Semiautomatic Coagulation AnalyzerKQG · Traditional | Texas Intl. Laboratories, Inc. | 04/16/1990SE |
| K862047 | Coagulator (8 Channel)KQG · Traditional | Med USA | 09/29/1986SE |
| K852492 | CoagulatorKQG · Traditional | Med USA | 08/13/1985SE |
| K851169 | Electra 800 Automatic Coagulation TimerKQG · Traditional | Medical Laboratory Automation Systems, Inc. | 06/24/1985SE |
| K823131 | Koagulab 40-A Automated Coagulation SysKQG · Traditional | Ortho Diagnostic Systems, Inc. | 12/09/1982SE |
More from Ortho Diagnostic Systems, Inc.
| 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 |
| K990449 | Hemochron Electronic System Verification TubeJPA · Traditional | 04/13/1999SE |
| K972866 | Hemochron Jr. Miocrocoagulation Citrated PTGJS · Traditional | 09/30/1998SE |
Questions and answers
When was Hemochron Response cleared by the FDA?
Hemochron Response (K983475) received a 510(k) decision of Substantially Equivalent on May 3, 1999, 213 days after the submission was received.
What is the product code of K983475?
The FDA product code is KQG – Instrument, Coagulation, a Class II (moderate risk) device regulated under 21 CFR 864.5400.