Coagulator (8 Channel)
FDA 510(k) K862047 · Med USA
510(k) numberK862047
Submission
- Device name
- Coagulator (8 Channel)
- Applicant
- Med USA
W. Concord, MA, US - Received
- May 29, 1986
- Decision date
- September 29, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| 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 |
| 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 |
| 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.
Questions and answers
When was Coagulator (8 Channel) cleared by the FDA?
Coagulator (8 Channel) (K862047) received a 510(k) decision of Substantially Equivalent on September 29, 1986, 123 days after the submission was received.
What is the product code of K862047?
The FDA product code is KQG – Instrument, Coagulation, a Class II (moderate risk) device regulated under 21 CFR 864.5400.