Technicon Ra-Xt System with Analytes
FDA 510(k) K862561 · Technicon Instruments Corp.
510(k) numberK862561
Submission
- Device name
- Technicon Ra-Xt System with Analytes
- Applicant
- Technicon Instruments Corp.
Tarrytown, NY, US - Received
- July 3, 1986
- Decision date
- October 20, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJC – Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2150
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JJC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K945915 | Avl Omni AnalyzerJJC · Traditional | Avl Scientific Corp. | 04/05/1995SE |
| K945584 | Nova 16 AnalyzerJJC · Traditional | Nova Biomedical Corp. | 02/08/1995SE |
| K943376 | Opera SystemJJC · Traditional | Miles, Inc. | 09/14/1994SE |
| K901410 | Technicon RA-2000(TM) SystemJJC · Traditional | Technicon Instruments Corp. | 07/17/1990SE |
| K901141 | Paramax 520, Paramax 720 and Paramax 720ZXJJC · Traditional | Baxter Healthcare Corp | 04/09/1990SE |
| K890332 | RFA/2 Rapid Flow Analyzer W/ComputerJJC · Traditional | Alpkem Corp. | 02/17/1989SE |
| K881056 | Amresco Flow Pac Random Access Liquid #4901030JJC · Traditional | American Research Products Co. | 11/15/1988SE |
| K875105 | Technicon Smac 3 SystemJJC · Traditional | Technicon Instruments Corp. | 02/16/1988SE |
| K870998 | Technicon Ra-Xt(Tm) System ImmunoassaysJJC · Traditional | Technicon Instruments Corp. | 05/26/1987SE |
| K854345 | Technicon RA-500 SystemJJC · Traditional | Technicon Instruments Corp. | 11/26/1985SE |
More from Technicon Instruments Corp.
| 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 Ra-Xt System with Analytes cleared by the FDA?
Technicon Ra-Xt System with Analytes (K862561) received a 510(k) decision of Substantially Equivalent on October 20, 1986, 109 days after the submission was received.
What is the product code of K862561?
The FDA product code is JJC – Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2150.