Synchron Systems Enzymatic CO2 (CO2E) Reagent, Model A60291
FDA 510(k) K091153 · Beckman Coulter, Inc.
510(k) numberK091153
Submission
- Device name
- Synchron Systems Enzymatic CO2 (CO2E) Reagent, Model A60291
- Applicant
- Beckman Coulter, Inc.
Brea, CA, US - Received
- April 21, 2009
- Decision date
- July 13, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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| K140248 | S Test Reagent Cartridge Carbon Dioxide (CO2)KHS · Traditional | Hitachi Chemical Diagnostics, Inc. | 03/11/2014SE |
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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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Questions and answers
When was Synchron Systems Enzymatic CO2 (CO2E) Reagent, Model A60291 cleared by the FDA?
Synchron Systems Enzymatic CO2 (CO2E) Reagent, Model A60291 (K091153) received a 510(k) decision of Substantially Equivalent on July 13, 2009, 83 days after the submission was received.
What is the product code of K091153?
The FDA product code is KHS – Enzymatic, Carbon-Dioxide, a Class II (moderate risk) device regulated under 21 CFR 862.1160.