Reflab System Pack Liquid CO2 Reagent
FDA 510(k) K926320 · Medical Analysis Systems, Inc.
510(k) numberK926320
Submission
- Device name
- Reflab System Pack Liquid CO2 Reagent
- Applicant
- Medical Analysis Systems, Inc.
Camarillo, CA, US - Received
- December 15, 1992
- Decision date
- February 3, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|---|
| 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 |
| K841080 | Technicon RA-1000 Sys CO2CHS · Traditional | Technicon Instruments Corp. | 05/02/1984SE |
| 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 |
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Questions and answers
When was Reflab System Pack Liquid CO2 Reagent cleared by the FDA?
Reflab System Pack Liquid CO2 Reagent (K926320) received a 510(k) decision of Substantially Equivalent on February 3, 1993, 50 days after the submission was received.
What is the product code of K926320?
The FDA product code is CHS – Coulometric Method, Carbon-Dioxide, a Class II (moderate risk) device regulated under 21 CFR 862.1160.