Technicon RA-1000 Sys CO2
FDA 510(k) K841080 · Technicon Instruments Corp.
510(k) numberK841080
Submission
- Device name
- Technicon RA-1000 Sys CO2
- Applicant
- Technicon Instruments Corp.
Mchenry, IL, US - Received
- March 13, 1984
- Decision date
- May 2, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CHS – Coulometric Method, Carbon-Dioxide
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1160
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CHS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K926320 | Reflab System Pack Liquid CO2 ReagentCHS · Traditional | Medical Analysis Systems, Inc. | 02/03/1993SE |
| K911838 | Roche Reagent for C02CHS · Traditional | Roche Diagnostic Systems, Inc. | 07/19/1991SE |
| K860660 | Amresco Flow Pac Carbon Dioxide (CO2) ReagentsCHS · Traditional | Amresco, Inc. | 03/14/1986SE |
| K811257 | Corning 965 Carbon Dioxide AnalyzerCHS · Traditional | Corning Medical & Scientific | 05/27/1981SE |
| K802376 | Kodak Ekta-Chem Clinical Chem. SlidesCHS · Traditional | Eastman Kodak Company | 10/23/1980SE |
More from Eastman Kodak Company
| 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-1000 Sys CO2 cleared by the FDA?
Technicon RA-1000 Sys CO2 (K841080) received a 510(k) decision of Substantially Equivalent on May 2, 1984, 50 days after the submission was received.
What is the product code of K841080?
The FDA product code is CHS – Coulometric Method, Carbon-Dioxide, a Class II (moderate risk) device regulated under 21 CFR 862.1160.