Data Zyme CO2 Procedure
FDA 510(k) K850903 · Data Medical Associates, Inc.
510(k) numberK850903
Submission
- Device name
- Data Zyme CO2 Procedure
- Applicant
- Data Medical Associates, Inc.
Arlington, TX, US - Received
- March 5, 1985
- Decision date
- April 8, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KHS – Enzymatic, Carbon-Dioxide
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1160
- Specialty
- Clinical Chemistry
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| K111960 | Elitech Clinical Systems Carbon Dioxide Electrode, Elitech Clinical Systems Ise…KHS · Traditional | Elitechgroup | 11/18/2011SE |
| K100060 | Eon 100 Chemistry Analyzer with Ise , Model 77105, Bicarbonate Reagent, Model 77475KHS · Traditional | Vital Diagnostics (Manufacturing) Ptyltd | 12/15/2010SE |
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| K952437 | Dma Glucose Hexokinase U.V. ProcedureCFR · Traditional | 10/03/1995SE |
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Questions and answers
When was Data Zyme CO2 Procedure cleared by the FDA?
Data Zyme CO2 Procedure (K850903) received a 510(k) decision of Substantially Equivalent on April 8, 1985, 34 days after the submission was received.
What is the product code of K850903?
The FDA product code is KHS – Enzymatic, Carbon-Dioxide, a Class II (moderate risk) device regulated under 21 CFR 862.1160.