Electra 800 Automatic Coagulation Timer
FDA 510(k) K851169 · Medical Laboratory Automation Systems, Inc.
510(k) numberK851169
Submission
- Device name
- Electra 800 Automatic Coagulation Timer
- Applicant
- Medical Laboratory Automation Systems, Inc.
Mount Vernon, NY, US - Received
- March 22, 1985
- Decision date
- June 24, 1985
- 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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| 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 |
| 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 |
|---|---|---|
| K962664 | Electra 1800C Automatic Coagulation AnalyzerGKP · Traditional | 09/10/1996SE |
| K944227 | Electra 1400C Automatic Coagulation AnalyzerGKP · Traditional | 02/03/1995SE |
| K931206 | Electra 1600C Automatic Coagulation TimerGKP · Traditional | 08/23/1993SE |
| K923220 | Thrombin Clot Time Test ProcedureGJA · Traditional | 09/29/1992SE |
| K903638 | Gastro-Intestinal Accu-Culshure TMLIO · Traditional | 01/18/1991SE |
| K903406 | Viral Accu-Culshure TMLIO · Traditional | 10/16/1990SE |
| K903405 | Chlamydia Accu-Culshure TMLIO · Traditional | 10/16/1990SE |
| K901645 | Anaerobic Accu-Culshure(Tm)JTX · Traditional | 07/16/1990SE |
| K894052 | Electra 1000C Automatic Coagulation TimerGKP · Traditional | 07/27/1989SE |
| K884863 | Electra 900C Automatic Coagulation TimerGKP · Traditional | 02/03/1989SE |
Questions and answers
When was Electra 800 Automatic Coagulation Timer cleared by the FDA?
Electra 800 Automatic Coagulation Timer (K851169) received a 510(k) decision of Substantially Equivalent on June 24, 1985, 94 days after the submission was received.
What is the product code of K851169?
The FDA product code is KQG – Instrument, Coagulation, a Class II (moderate risk) device regulated under 21 CFR 864.5400.