FDA Product Code
FDA Product Code JHX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1215
510(k) Clearances — 48 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K234005 | Access CK-MB | Beckman Coulter, Inc. | 2024-02-16 | Traditional | PDF ↗ |
| K212648 | VITROS Immunodiagnostic Products CK-MB Reagent Pack | Ortho Clinical Diagnostics | 2022-01-28 | Traditional | PDF ↗ |
| K163462 | AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX | Radiometer Medical Aps | 2017-09-21 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K081360 | PATHFAST CK-MB-II, PATHFAST MYO-II | Mitsubishi Kagaku Iatron | 2009-08-17 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K041596 | ARCHITECT STAT CK-MB IMMUNOASSAY | Fisher Diagnostics | 2004-07-21 | Traditional | PDF ↗ |
| K033747 | RAMP CK-MB ASSAY | Response Biomedical Corp. | 2004-05-17 | Traditional | PDF ↗ |
| K034055 | IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I | Diagnostic Products Corp. | 2004-01-21 | Special | PDF ↗ |
| K030012 | CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371 AND 386372 | Beckman Coulter, Inc. | 2003-01-17 | Special | PDF ↗ |
| K022118 | IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS) | Diagnostic Products Corp. | 2002-07-22 | Special | PDF ↗ |
| K013118 | MODIFICATION TO ALPHA DX SYSTEM | First Medical, Inc. | 2001-10-15 | Special | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K000716 | ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER | Beckman Coulter, Inc. | 2000-03-20 | Special | PDF ↗ |
| K994439 | ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33300, 33305, 33309, 33306 | Beckman Coulter, Inc. | 2000-01-14 | Traditional | PDF ↗ |
| K993068 | VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK ; VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORS | Ortho-Clinical Diagnostics | 1999-10-04 | Special | PDF ↗ |
| K991797 | IMMULITE TURBO CK-MB, MODELS LSKCP1, LSKCP5 | Diagnostic Products Corp. | 1999-06-09 | Special | PDF ↗ |
| K984067 | STRATUS (R) CS STAT FLUOROMETRIC ANALYZER, STRATUS (R) CS CKMB TEST PAK | Dade Behring, Inc. | 1999-01-13 | Traditional | PDF ↗ |
| K981099 | STRATUS CS STAT FLUOROMETRIC ANALYZER AND STRATUS CS CKMB TESTPAK | Dade Behring, Inc. | 1998-05-26 | Traditional | PDF ↗ |
| K980012 | CREATINE KINASE REAGENT | Ac Biochemicals, Inc. | 1998-02-25 | Traditional | PDF ↗ |
| K973126 | TRIAGE CARDIAC PANEL, TRIAGE TROPONIN-I, TRIAGE CK-MB, TRIAGE MYOGLOBIN, TRIAGE TROPONIN-I AND CK-MB, TRIAGE TROPONIN-I | Biosite Incorporated | 1997-10-06 | Traditional | PDF ↗ |
| K972782 | DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY | Dade Intl., Inc. | 1997-08-15 | Traditional | PDF ↗ |
| K962549 | VIDAS CREATINE KINASE MB ASSAY 30-421 | Biomerieux Vitek, Inc. | 1996-08-30 | Traditional | PDF ↗ |
| K913380 | MYDAS(TM)-MB2/MYDAS(TM)-MB | Intl. Immunoassay Laboratories, Inc. | 1992-04-22 | Traditional | PDF ↗ |
| K913298 | AIA-PACK CK-MB | Tosoh Corp. | 1991-09-27 | Traditional | PDF ↗ |
| K911121 | CIBA CORNING ACS CKMB IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1991-04-03 | Traditional | PDF ↗ |
| K903441 | MYDAS(TM) BRAND SOLID-PHASE ANTIBODY REAGENTS | Intl. Immunoassay Laboratories, Inc. | 1990-11-06 | Traditional | PDF ↗ |
| K890543 | IMPRES-MB REAGENT A AND REAGENT B | Intl. Immunoassay Laboratories, Inc. | 1989-03-13 | Traditional | PDF ↗ |
| K881267 | BIOTROL CK MONOEACTIF | Biotrol, USA, Inc. | 1988-05-16 | Traditional | PDF ↗ |
| K881237 | CREATINE KINASE (CK) REAGENT SET | Tech-Neal Scientific, Inc. | 1988-04-28 | Traditional | PDF ↗ |
| K874144 | TITAN GEL REP CPK-6 HV | Helena Laboratories | 1987-11-23 | Traditional | PDF ↗ |
| K873399 | TITAN GEL CPK REP SYSTEM | Helena Laboratories | 1987-10-20 | Traditional | PDF ↗ |
| K873171 | STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY | American Dade | 1987-09-29 | Traditional | PDF ↗ |
| K870987 | CIBA CORNING MAGIC(R) LITE CKMB IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1987-05-26 | Traditional | PDF ↗ |
| K840549 | CK-B RIA KIT | Diagnostic Systems Laboratories, Inc. | 1984-05-07 | Traditional | PDF ↗ |
| K813573 | CARDIOTRAC CORNING CK ISOENZYME SUBST | Corning Medical & Scientific | 1982-01-18 | Traditional | PDF ↗ |
| K813087 | ABURIA-CK RIA TEST KIT | Intl. Immunoassay Laboratories, Inc. | 1981-12-17 | Traditional | PDF ↗ |
| K812759 | NML CK-MB RIA | Nuclear Medical Laboratories, Inc. | 1981-10-19 | Traditional | PDF ↗ |
| K802826 | PARAGON ELECTRO. CREATINE KINASE TEST KI | Beckman Instruments, Inc. | 1981-01-09 | Traditional | PDF ↗ |
| K801728 | EMBRIA-CK | Intl. Immunoassay Laboratories, Inc. | 1980-09-26 | Traditional | PDF ↗ |
| K801318 | HELENA ULTRA SENSITIVE CPK REAGENT/DILUE | Helena Laboratories | 1980-07-14 | Traditional | PDF ↗ |
| K800544 | CORNING TRANSPHOR | Corning Medical & Scientific | 1980-03-20 | Traditional | PDF ↗ |
| K792504 | RIA-QUANT CK-MB TEST KIT | Mallinckrodt Critical Care | 1980-01-16 | Traditional | PDF ↗ |
| K791582 | CARDIO CK-B RIA KIT | Nuclear Medical Systems, Inc. | 1979-11-15 | Traditional | PDF ↗ |
| K790294 | BUFFER, CORNING MOPSO | Corning Medical & Scientific | 1979-03-21 | Traditional | PDF ↗ |
| K771605 | CREATINE KINASE ISOENZYME SUBSTRATE SET | Pfizer Pharmaceuticals | 1977-09-15 | Traditional | PDF ↗ |
| K771324 | 3-(N-MORPHOLINS)-PROPANE SULFONIC ACID | Corning Medical & Scientific | 1977-09-02 | Traditional | PDF ↗ |
| K760591 | SIGMA PROCEDURE NO. 745 - EP.REAGENT SY | Sigma Chemical Co. | 1976-10-29 | Traditional | PDF ↗ |
Product code JHX · Class II · Clinical Chemistry. Data: openFDA.