Technicon Ra Systems Sodium (Colorimetric Method)
FDA 510(k) K896829 · Technicon Instruments Corp.
510(k) numberK896829
Submission
- Device name
- Technicon Ra Systems Sodium (Colorimetric Method)
- Applicant
- Technicon Instruments Corp.
Tarrytown, NY, US - Received
- December 4, 1989
- Decision date
- February 23, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JGT – Flame Photometry, Sodium
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1665
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JGT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K891574 | Lithium Concentrate #SR1031, Na/K Standards SR1030JGT · Traditional | Em Diagnostic Systems, Inc. | 06/09/1989SE |
| K841610 | Components for Potassium, Sodium ChloJGT · Traditional | Shaban Mfg. Co. | 05/25/1984SE |
| K840216 | Sodium/Potassium Reagent SysJGT · Traditional | Sclavo, Inc. | 03/19/1984SE |
| K834248 | Parallel Flame Photometer & SodiumJGT · Traditional | American Monitor Corp. | 01/30/1984SE |
| K811886 | Cesium Diluent 7.5MJGT · Traditional | Gilford Diagnostics | 07/23/1981SE |
| K801892 | Klinar Reagent Pak, #36010JGT · Traditional | Hi Chem, Inc. | 10/23/1980SE |
| K770774 | Lytetek SystemJGT · Traditional | Boehringer Mannheim Corp. | 07/11/1977SE |
More from Boehringer Mannheim 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 Systems Sodium (Colorimetric Method) cleared by the FDA?
Technicon Ra Systems Sodium (Colorimetric Method) (K896829) received a 510(k) decision of Substantially Equivalent on February 23, 1990, 81 days after the submission was received.
What is the product code of K896829?
The FDA product code is JGT – Flame Photometry, Sodium, a Class II (moderate risk) device regulated under 21 CFR 862.1665.