ABL555 Blood Gas, Electrolyte & Metabolite System
FDA 510(k) K974818 · Radiometer America, Inc.
510(k) numberK974818
Submission
- Device name
- ABL555 Blood Gas, Electrolyte & Metabolite System
- Applicant
- Radiometer America, Inc.
Westlake, OH, US - Received
- December 23, 1997
- Decision date
- January 16, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MMI – Immunoassay Method, Troponin Subunit
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1215
- Specialty
- Clinical Chemistry
Other 510(k)s with product code MMI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253051 | i-STAT hs-TnI cartridge with the i-STAT Alinity SystemMMI · Traditional | Abbott Point of Care, Inc. | 06/11/2026SE |
| K252393 | VITROS Immunodiagnostic Products hs Troponin I Reagent PackMMI · Traditional | Ortho-Clinical Diagnostics, Inc. | 10/29/2025SE |
| K243483 | Access hsTnIMMI · Traditional | Beckman Coulter, Inc. | 08/01/2025SE |
| K242870 | Access hsTnIMMI · Traditional | Beckman Coulter, Inc. | 06/16/2025SE |
| K240984 | i-STAT hs-TnI cartridge with the i-STAT 1 SystemMMI · Traditional | Abbott Point of Care, Inc. | 01/03/2025SE |
| K241165 | Atellica® IM High-Sensitivity Troponin I (TnIH)MMI · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/25/2024SE |
| K231974 | PATHFAST®hs-cTnI-IIMMI · Traditional | Phc Corporation | 03/20/2024SE |
| K222881 | Access hsTnIMMI · Traditional | Beckman Coulter, Inc. | 12/18/2023SE |
| K230648 | Access hsTnIMMI · Traditional | Beckman Coulter, Inc. | 12/04/2023SE |
| K230994 | Alinity i STAT High Sensitivity Troponin-IMMI · Special | Abbott Laboratories Diagnostics Division | 05/04/2023SE |
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| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K973367 | ABL555 Blood Gas, Electrolyte & Metabolite SystemCHL · Traditional | 10/06/1997SE |
| K962158 | Pico Models 30, 50, 70JKA · Traditional | 10/29/1996SE |
| K962334 | EML105 Electrolyte Metabolite AnalyzerJGS · Traditional | 10/24/1996SE |
| K961355 | MulticheckJJS · Traditional | 06/14/1996SE |
Questions and answers
When was ABL555 Blood Gas, Electrolyte & Metabolite System cleared by the FDA?
ABL555 Blood Gas, Electrolyte & Metabolite System (K974818) received a 510(k) decision of Substantially Equivalent on January 16, 1998, 24 days after the submission was received.
What is the product code of K974818?
The FDA product code is MMI – Immunoassay Method, Troponin Subunit, a Class II (moderate risk) device regulated under 21 CFR 862.1215.