JHX — Fluorometric Method, Cpk Or Isoenzymes Class II
FDA product code JHX covers "Fluorometric Method, Cpk Or Isoenzymes", a Class II medical device regulated under 21 CFR 862.1215. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JHX
- Device Class
- Class II
- Regulation Number
- 862.1215
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K234005 | Beckman Coulter | Access CK-MB | Feb 16, 2024 |
| K212648 | Ortho Clinical Diagnostics | VITROS Immunodiagnostic Products CK-MB Reagent Pack | Jan 28, 2022 |
| K163462 | Radiometer Medical Aps | AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX | Sep 21, 2017 |
| K120326 | Radiometer Medical Aps | AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKM | Nov 21, 2012 |
| K081360 | Mitsubishi Kagaku Iatron | PATHFAST CK-MB-II, PATHFAST MYO-II | Aug 17, 2009 |
| K051650 | Dade Behring | STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS C | Sep 8, 2005 |
| K041596 | Fisher Diagnostics | ARCHITECT STAT CK-MB IMMUNOASSAY | Jul 21, 2004 |
| K033747 | Response Biomedical | RAMP CK-MB ASSAY | May 17, 2004 |
| K034055 | Diagnostic Products | IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I | Jan 21, 2004 |
| K030012 | Beckman Coulter | CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371 AND | Jan 17, 2003 |
| K022118 | Diagnostic Products | IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS) | Jul 22, 2002 |
| K013118 | First Medical | MODIFICATION TO ALPHA DX SYSTEM | Oct 15, 2001 |
| K004002 | Diagnostic Products | IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS); IMMULITE 2000 CK-MB, | Feb 14, 2001 |
| K000716 | Beckman Coulter | ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER | Mar 20, 2000 |
| K994439 | Beckman Coulter | ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33300, 33305, 33309, 333 | Jan 14, 2000 |
| K993068 | Ortho-Clinical Diagnostics | VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK ; VITROS IMMUNODIAGNOSTIC PR | Oct 4, 1999 |
| K991797 | Diagnostic Products | IMMULITE TURBO CK-MB, MODELS LSKCP1, LSKCP5 | Jun 9, 1999 |
| K984067 | Dade Behring | STRATUS (R) CS STAT FLUOROMETRIC ANALYZER, STRATUS (R) CS CKMB TEST PAK | Jan 13, 1999 |
| K981099 | Dade Behring | STRATUS CS STAT FLUOROMETRIC ANALYZER AND STRATUS CS CKMB TESTPAK | May 26, 1998 |
| K980012 | Ac Biochemicals | CREATINE KINASE REAGENT | Feb 25, 1998 |