Elvi 828 Digiclot Multiscan
FDA 510(k) K902614 · Logos Scientific, Inc.
510(k) numberK902614
Submission
- Device name
- Elvi 828 Digiclot Multiscan
- Applicant
- Logos Scientific, Inc.
Henderson, NV, US - Received
- June 13, 1990
- Decision date
- November 8, 1990
- 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
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| 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 |
| 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 |
|---|---|---|
| K843375 | Elvi 655 Flame PhotometerJJO · Traditional | 05/20/1985SE |
| K844710 | Eurochima Serum Protein Electrophoresis MethodJJN · Traditional | 01/07/1985SE |
| K843296 | Elvi 675 DigitronJJQ · Traditional | 09/13/1984SE |
| K842313 | Elvi 146 SeroscanJQT · Traditional | 09/10/1984SE |
| K842056 | Elvi 165 Proteo SeroskopJQT · Traditional | 06/22/1984SE |
| K841804 | Elvi 70 Safety ChamberJJN · Traditional | 05/31/1984SE |
| K840757 | Elvi 444 BilitronCIG · Traditional | 05/30/1984SE |
| K841288 | Elvi 18JJN · Traditional | 05/02/1984SE |
Questions and answers
When was Elvi 828 Digiclot Multiscan cleared by the FDA?
Elvi 828 Digiclot Multiscan (K902614) received a 510(k) decision of Substantially Equivalent on November 8, 1990, 148 days after the submission was received.
What is the product code of K902614?
The FDA product code is KQG – Instrument, Coagulation, a Class II (moderate risk) device regulated under 21 CFR 864.5400.