EML105 Electrolyte Metabolite Analyzer
FDA 510(k) K962334 · Radiometer America, Inc.
510(k) numberK962334
Submission
- Device name
- EML105 Electrolyte Metabolite Analyzer
- Applicant
- Radiometer America, Inc.
Westlake, OH, US - Received
- June 17, 1996
- Decision date
- October 24, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JGS – Electrode, Ion Specific, Sodium
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1665
- Specialty
- Clinical Chemistry
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| K222438 | A-LYTE® Integrated Multisensor (IMT Na K Cl)JGS · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/25/2023SE |
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| K213486 | GLP systems TrackJGS · Traditional | Abbott Laboratories | 03/10/2022SE |
| K200403 | Stat Profile Prime Plus Analyzer SystemJGS · Traditional | Nova Biomedical Corporation | 04/14/2020SE |
| K183688 | i-STAT CHEM8+ cartridge with the i-STAT 1 SystemJGS · Traditional | Abbott Point of Care, Inc. | 02/07/2020SE |
| K191365 | Stat Profile Prime ES Comp Plus Analyzer SystemJGS · Traditional | Nova Biomedical Corporation | 07/19/2019SE |
| K172232 | LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600JGS · Traditional | Ams Diagnostics | 06/12/2019SE |
| K183549 | GEM Premier ChemSTATJGS · Traditional | Instrumentation Laboratory CO | 02/16/2019SE |
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| 510(k) | Device | Decision |
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| K153712 | VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification…JJY · Traditional | 01/28/2016SE |
| K992859 | ABL700 Series Analyzer with Autocheck ModuleCHL · Special | 01/10/2000SE |
| K991417 | Abl 735 AnalyzerCHL · Traditional | 11/24/1999SE |
| K982928 | NPT7 Series Ph/Blood Gas and Co-Oximetry SystemCHL · Traditional | 01/06/1999SE |
| K980130 | ABL700 Series Blood Gas , Co-Oximetry, Electrolyte & Metabolite SystemCHL · Traditional | 02/09/1998SE |
| K980135 | QUALICHECK5+ Models S7730, S7740, S7750, S7760JJS · Traditional | 01/28/1998SE |
| K974818 | ABL555 Blood Gas, Electrolyte & Metabolite SystemMMI · Traditional | 01/16/1998SE |
| K973367 | ABL555 Blood Gas, Electrolyte & Metabolite SystemCHL · Traditional | 10/06/1997SE |
| K962158 | Pico Models 30, 50, 70JKA · Traditional | 10/29/1996SE |
| K961355 | MulticheckJJS · Traditional | 06/14/1996SE |
Questions and answers
When was EML105 Electrolyte Metabolite Analyzer cleared by the FDA?
EML105 Electrolyte Metabolite Analyzer (K962334) received a 510(k) decision of Substantially Equivalent on October 24, 1996, 129 days after the submission was received.
What is the product code of K962334?
The FDA product code is JGS – Electrode, Ion Specific, Sodium, a Class II (moderate risk) device regulated under 21 CFR 862.1665.