Technicon Gen 2 Sys & Analytes LD, Alp CK, Un, in
FDA 510(k) K850999 · Technicon Instruments Corp.
510(k) numberK850999
Submission
- Device name
- Technicon Gen 2 Sys & Analytes LD, Alp CK, Un, in
- Applicant
- Technicon Instruments Corp.
Tarrytown, NY, US - Received
- March 11, 1985
- Decision date
- April 8, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJF – Analyzer, Chemistry, Micro, For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2170
- Specialty
- Clinical Chemistry
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| K033734 | Lightcycler Instrument Version 1.2JJF · Traditional | Roche Diagnostics Corp. | 12/17/2003SE |
| K013654 | Precision Systems Analette Chemistry AnalyzerJJF · Traditional | Precision Systems, Inc. | 06/05/2002SE |
| K012966 | Roche Cobas Taqman AnalyzerJJF · Traditional | Roche Molecular Systems, Inc. | 02/01/2002SE |
| K993634 | Careside AnalyzerJJF · Traditional | Careside, Inc. | 12/02/1999SE |
| K973628 | Vitalab Flexor/Vitalab Selectra 2/VITALAB VivaJJF · Traditional | Vital Scientific N.V. | 03/13/1998SE |
| K980056 | Careside AnalyzerJJF · Traditional | Exigent Diagnostics, Inc. | 03/06/1998SE |
| K973177 | Mago Automated Eia ProcessorJJF · Traditional | Diamedix Corp. | 10/09/1997SE |
| K971491 | Synermed Ir 200 Chemistry AnalyzerJJF · Traditional | Synermed, Inc. | 06/26/1997SE |
More from Synermed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K914888 | Technicon Chem 1(TM) Syst (GEN2 Syst)CIX · Traditional | 11/27/1991SE |
| K914511 | Technicon Axon(Tm) System Methods Anyalye HDL CholLBS · Traditional | 11/27/1991SE |
| K914025 | Technicon Axon(Tm) Systems, Alt(P 5-P)/AST(P 5-P)CIT · Traditional | 11/22/1991SE |
| K912616 | Technicon Immuno 1 TM System Additional AnalytesKLI · Traditional | 09/25/1991SE |
| K912413 | Chem-Link Data Base ManagerJJQ · Traditional | 07/01/1991SE |
| K903825 | Drug of Abuse Analysis SystemDIS · Traditional | 09/27/1990SE |
| K903824 | Drug of Abuse Analysis System Free Radical AssayDKZ · Traditional | 09/27/1990SE |
| K903305 | Technicon Chem I System Carbon Dioxide MethodKHS · Traditional | 09/27/1990SE |
| K903306 | Technicon Chem I System Magnesium MethodJGJ · Traditional | 08/29/1990SE |
| K901410 | Technicon RA-2000(TM) SystemJJC · Traditional | 07/17/1990SE |
Questions and answers
When was Technicon Gen 2 Sys & Analytes LD, Alp CK, Un, in cleared by the FDA?
Technicon Gen 2 Sys & Analytes LD, Alp CK, Un, in (K850999) received a 510(k) decision of Substantially Equivalent on April 8, 1985, 28 days after the submission was received.
What is the product code of K850999?
The FDA product code is JJF – Analyzer, Chemistry, Micro, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2170.