AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX
FDA 510(k) clearance K163462 · decided 2017-09-21
Clearance details
- K-number
- K163462
- Device name
- AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX
- Applicant
- Radiometer Medical Aps
- Decision
- Substantially Equivalent
- Date received
- 2016-12-09
- Decision date
- 2017-09-21
- Days to decision
- 286 days
- Clearance type
- Traditional
- Product code
- JHX
- Device class
- 2
- Regulation number
- 862.1215
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Dk-Bronshoj, DK
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| Access CK-MB (K234005) | Beckman Coulter, Inc. | 2024-02-16 |
| VITROS Immunodiagnostic Products CK-MB Reagent Pack (K212648) | Ortho Clinical Diagnostics | 2022-01-28 |
| AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGE (K120326) | Radiometer Medical Aps | 2012-11-21 |
| PATHFAST CK-MB-II, PATHFAST MYO-II (K081360) | Mitsubishi Kagaku Iatron | 2009-08-17 |
| STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK. (K051650) | Dade Behring, Inc. | 2005-09-08 |
| ARCHITECT STAT CK-MB IMMUNOASSAY (K041596) | Fisher Diagnostics | 2004-07-21 |
| RAMP CK-MB ASSAY (K033747) | Response Biomedical Corp. | 2004-05-17 |
| IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I (K034055) | Diagnostic Products Corp. | 2004-01-21 |
| CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371 AND 386372 (K030012) | Beckman Coulter, Inc. | 2003-01-17 |
| IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS) (K022118) | Diagnostic Products Corp. | 2002-07-22 |
| MODIFICATION TO ALPHA DX SYSTEM (K013118) | First Medical, Inc. | 2001-10-15 |
| IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS); IMMULITE 2000 CK-MB, MODEL L2KMB2 (200 TESTS), L2KMB6 (600) (K004002) | Diagnostic Products Corp. | 2001-02-14 |
Recalls involving this device
No recalls on record reference this clearance.