AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX
FDA 510(k) K163462 · Radiometer Medical Aps
510(k) numberK163462
Submission
- Device name
- AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX
- Applicant
- Radiometer Medical Aps
Dk-Bronshoj, DK - Received
- December 9, 2016
- Decision date
- September 21, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JHX – Fluorometric Method, Cpk Or Isoenzymes
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1215
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JHX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K234005 | Access CK-MBJHX · Traditional | Beckman Coulter, Inc. | 02/16/2024SE |
| K212648 | VITROS Immunodiagnostic Products CK-MB Reagent PackJHX · Traditional | Ortho Clinical Diagnostics | 01/28/2022SE |
| K120326 | AQT90 Flex CKMB Test Kit, AQT90 Flex LQC Multi-Check, Levels 1-3, AQT90 Flex CKMB Cal…JHX · Traditional | Radiometer Medical Aps | 11/21/2012SE |
| K081360 | Pathfast Ck-Mb-Ii, Pathfast Myo-IiJHX · Traditional | Mitsubishi Kagaku Iatron | 08/17/2009SE |
| K051650 | Stratus CS Acute Care MB Isoenzyme of Creatine Kinase (CKMB) Test Pak; Stratus CS Acute…JHX · Traditional | Dade Behring, Inc. | 09/08/2005SE |
| K041596 | Architect Stat Ck-Mb ImmunoassayJHX · Traditional | Fisher Diagnostics | 07/21/2004SE |
| K033747 | Ramp Ck-Mb AssayJHX · Traditional | Response Biomedical Corp. | 05/17/2004SE |
| K034055 | Immulite 2500 Ck-Mb, 2500 Myoglobin, 2500 Stat Troponin IJHX · Special | Diagnostic Products Corp. | 01/21/2004SE |
| K030012 | Ck-Mb and Ck-Mb Calibrators on the Access Immunoassay Systems, Models 386371 and 386372JHX · Special | Beckman Coulter, Inc. | 01/17/2003SE |
| K022118 | Immulite Turbo Ck-Mb, Models LSKCP1 (100 Tests), LSKCP5 (500 Tests)JHX · Special | Diagnostic Products Corp. | 07/22/2002SE |
More from Diagnostic Products Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K170882 | ABL90 Flex, ABL90 Flex PlusMQM · Traditional | 04/28/2017SE |
| K160153 | ABL90 Flex PlusCHL · Special | 11/04/2016SE |
| K142898 | ABL800 FLEX with AQURE connectivityCHL · Special | 06/17/2015SE |
| K150226 | Hematocrit and Metabolite QUALICHECKJJS · Traditional | 05/13/2015SE |
| K132691 | ABL90 FlexMQM · Traditional | 11/13/2014SE |
| K131988 | ABL90 Flex AnalyzerCHL · Traditional | 09/17/2013SE |
| K130144 | ABL90 FlexCHL · Special | 07/31/2013SE |
| K123748 | ABL90 FlexCHL · Special | 05/07/2013SE |
| K130415 | High Metabolite QualicheckJJS · Traditional | 03/26/2013SE |
| K130236 | Range + Qualicheck Level 1, Range + Qualicheck Level 2, Range + Qualicheck Level 3JJS · Traditional | 03/15/2013SE |
Questions and answers
When was AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX cleared by the FDA?
AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX (K163462) received a 510(k) decision of Substantially Equivalent on September 21, 2017, 286 days after the submission was received.
What is the product code of K163462?
The FDA product code is JHX – Fluorometric Method, Cpk Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1215.