Electra 1400C Automatic Coagulation Analyzer
FDA 510(k) K944227 · Medical Laboratory Automation Systems, Inc.
510(k) numberK944227
Submission
- Device name
- Electra 1400C Automatic Coagulation Analyzer
- Applicant
- Medical Laboratory Automation Systems, Inc.
Pleasantville, NY, US - Received
- September 1, 1994
- Decision date
- February 3, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GKP – Instrument, Coagulation, Automated
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5400
- Specialty
- Hematology
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| K063679 | Acl TopGKP · Special | Instrumentation Laboratory CO | 01/12/2007SE |
| K033414 | Acl Top Model, TopGKP · Abbreviated | Instrumentation Laboratory CO | 01/12/2004SE |
| K031377 | Sysmex Automated Coagulation Analyzer CA500 Series (CA-510, -520, -530, -540. -550, and…GKP · Traditional | Dade Behring, Inc. | 09/08/2003SE |
| K023362 | Fisher Diagnostics Thromboscreen 1000; Pacific Hemostasis Fibrinogen Reagent Plus KaolinGKP · Traditional | Fisher Diagnostics | 12/09/2002SE |
More from Fisher Diagnostics
| 510(k) | Device | Decision |
|---|---|---|
| K962664 | Electra 1800C Automatic Coagulation AnalyzerGKP · Traditional | 09/10/1996SE |
| 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 |
| K871687 | Tytem(R) Reagent DispenserJQW · Traditional | 05/20/1987SE |
Questions and answers
When was Electra 1400C Automatic Coagulation Analyzer cleared by the FDA?
Electra 1400C Automatic Coagulation Analyzer (K944227) received a 510(k) decision of Substantially Equivalent on February 3, 1995, 155 days after the submission was received.
What is the product code of K944227?
The FDA product code is GKP – Instrument, Coagulation, Automated, a Class II (moderate risk) device regulated under 21 CFR 864.5400.