510(k) K163462
- Device
- AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX
- Applicant
- Radiometer Medical ApS
- 510(k) number
- K163462
- Product code
- JHX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-09-21
- Date received
- 2016-12-09
- Regulation
- 862.1215
- Classification name
- Fluorometric Method, Cpk Or Isoenzymes
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Per Pape Thomsen
- Address
- Aakandevej 21 Dk-Bronshoj DK 2700 2700
FDA Registration Numbers#
- 3013982035
- 3006198300
- 3005360469
- 1181121
- 9680746
- 3014353045
- 3005333358
- 2432235
- 3012963943
- 2250051
- 3004205692
- 3008344661
- 3002809144
- 9612316
- 1036362
- 2517506
- 2122870
- 8031673
- 3002637618
- 9610987
- 3002642396
- 3029973107
- 3007135420
- 1219913
- 3005529799
- 3007111389
- 3003366417
- 1319681
- 2435505
- 3000308930
- 3002806944
Source Documents#
Other 510(k) Records For Product Code JHX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K234005 | Access CK-MB | Beckman Coulter, Inc. | 2024-02-16 |
| K212648 | VITROS Immunodiagnostic Products CK-MB Reagent Pack | Ortho Clinical Diagnostics | 2022-01-28 |
| K120326 | AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGE | Radiometer Medical Aps | 2012-11-21 |
| K081360 | PATHFAST CK-MB-II, PATHFAST MYO-II | Mitsubishi Kagaku Iatron | 2009-08-17 |
| K051650 | STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK. | Dade Behring, Inc. | 2005-09-08 |
| K041596 | ARCHITECT STAT CK-MB IMMUNOASSAY | Fisher Diagnostics | 2004-07-21 |
| K033747 | RAMP CK-MB ASSAY | Response Biomedical Corp. | 2004-05-17 |
| K034055 | IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I | Diagnostic Products Corp. | 2004-01-21 |
| K030012 | CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371 AND 386372 | Beckman Coulter, Inc. | 2003-01-17 |
| K022118 | IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS) | Diagnostic Products Corp. | 2002-07-22 |
| K013118 | MODIFICATION TO ALPHA DX SYSTEM | First Medical, Inc. | 2001-10-15 |
| K004002 | IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS); IMMULITE 2000 CK-MB, MODEL L2KMB2 (200 TESTS), L2KMB6 (600) | Diagnostic Products Corp. | 2001-02-14 |
| K000716 | ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER | Beckman Coulter, Inc. | 2000-03-20 |
| K994439 | ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33300, 33305, 33309, 33306 | Beckman Coulter, Inc. | 2000-01-14 |
| K993068 | VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK ; VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORS | Ortho-Clinical Diagnostics | 1999-10-04 |
Legacy Summary#
summary
FDA Review#
Decision Summary