FIBRON-1, FIBRON-4, Quikcoag, Fibron
FDA 510(k) K021976 · Vital Scientific N.V.
510(k) numberK021976
Submission
- Device name
- FIBRON-1, FIBRON-4, Quikcoag, Fibron
- Applicant
- Vital Scientific N.V.
Newton, MA, US - Received
- June 17, 2002
- Decision date
- October 25, 2002
- 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
Other 510(k)s with product code KQG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K050821 | Coagcare Anticoagulation Management SystemKQG · Traditional | Zycare | 08/16/2005SE |
| K992130 | Pacific Hemostasis Thromboscreen 400CKQG · Traditional | Pacific Hemostasis | 09/03/1999SE |
| K991321 | Pacific Hemostasis Thromboscreen 200KQG · Traditional | Pacific Hemostasis | 06/21/1999SE |
| K983475 | Hemochron ResponseKQG · Traditional | International Technidyne Corp. | 05/03/1999SE |
| 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 |
|---|---|---|
| K022021 | Vital Scientific Aptt, Aptt & Quikcoag ApttGFO · Traditional | 11/01/2002SE |
| K022046 | Vital Scientific Coagulation Control,Coagulation Control Level 1,2,3,QUIKCOAG…GGN · Traditional | 07/23/2002SE |
| K020840 | Vital Scientific PT with CalciumGJS · Traditional | 05/15/2002SE |
| K973628 | Vitalab Flexor/Vitalab Selectra 2/VITALAB VivaJJF · Traditional | 03/13/1998SE |
Questions and answers
When was FIBRON-1, FIBRON-4, Quikcoag, Fibron cleared by the FDA?
FIBRON-1, FIBRON-4, Quikcoag, Fibron (K021976) received a 510(k) decision of Substantially Equivalent on October 25, 2002, 130 days after the submission was received.
What is the product code of K021976?
The FDA product code is KQG – Instrument, Coagulation, a Class II (moderate risk) device regulated under 21 CFR 864.5400.