Product code JHX— Clinical Chemistry
3-(N-MORPHOLINS)-PROPANE SULFONIC ACID
- Classification name
- Fluorometric Method, Cpk Or Isoenzymes
- Device class
- Class 2
- Regulation
- 21 CFR 862.1215
- Advisory panel
- Clinical Chemistry
- Total cleared
- 48
- First cleared
- Most recent
Market context for product code JHX
FDA has cleared devices under product code JHX between 1976 and 2024, filed by 28 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2024
- 2022
- 2017
- 2012
- 2009
- 2005
- 2004
- 2003
- 2002
- 2001
- 2000
- 1999
- 1998
- 1997
- 1996
Top applicants under product code JHX
Recent clearances under product code JHX
- K234005 — Access CK-MB
- K212648 — VITROS Immunodiagnostic Products CK-MB Reagent Pack
- K163462 — AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX
- K120326 — AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGE
- K081360 — PATHFAST CK-MB-II, PATHFAST MYO-II
- K051650 — STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK.
- K041596 — ARCHITECT STAT CK-MB IMMUNOASSAY
- K033747 — RAMP CK-MB ASSAY
- K034055 — IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I
- K030012 — CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371 AND 386372
- K022118 — IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS)
- K013118 — MODIFICATION TO ALPHA DX SYSTEM
- K004002 — IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS); IMMULITE 2000 CK-MB, MODEL L2KMB2 (200 TESTS), L2KMB6 (600)
- K000716 — ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER
- K994439 — ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33300, 33305, 33309, 33306
- K993068 — VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK; VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORS
- K991797 — IMMULITE TURBO CK-MB, MODELS LSKCP1, LSKCP5
- K984067 — STRATUS (R) CS STAT FLUOROMETRIC ANALYZER, STRATUS (R) CS CKMB TEST PAK
- K981099 — STRATUS CS STAT FLUOROMETRIC ANALYZER AND STRATUS CS CKMB TESTPAK
- K980012 — CREATINE KINASE REAGENT
- K973126 — TRIAGE CARDIAC PANEL, TRIAGE TROPONIN-I, TRIAGE CK-MB, TRIAGE MYOGLOBIN, TRIAGE TROPONIN-I AND CK-MB, TRIAGE TROPONIN-I
- K972782 — DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY
- K962549 — VIDAS CREATINE KINASE MB ASSAY 30-421
- K913380 — MYDAS(TM)-MB2/MYDAS(TM)-MB
- K913298 — AIA-PACK CK-MB
- K911121 — CIBA CORNING ACS CKMB IMMUNOASSAY
- K903441 — MYDAS(TM) BRAND SOLID-PHASE ANTIBODY REAGENTS
- K890543 — IMPRES-MB REAGENT A AND REAGENT B
- K881267 — BIOTROL CK MONOEACTIF
- K881237 — CREATINE KINASE (CK) REAGENT SET
- K874144 — TITAN GEL REP CPK-6 HV
- K873399 — TITAN GEL CPK REP SYSTEM
- K873171 — STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY
- K870987 — CIBA CORNING MAGIC(R) LITE CKMB IMMUNOASSAY
- K840549 — CK-B RIA KIT
- K813573 — CARDIOTRAC CORNING CK ISOENZYME SUBST
- K813087 — ABURIA-CK RIA TEST KIT
- K812759 — NML CK-MB RIA
- K802826 — PARAGON ELECTRO. CREATINE KINASE TEST KI
- K801728 — EMBRIA-CK
- K801318 — HELENA ULTRA SENSITIVE CPK REAGENT/DILUE
- K800544 — CORNING TRANSPHOR
- K792504 — RIA-QUANT CK-MB TEST KIT
- K791582 — CARDIO CK-B RIA KIT
- K790294 — BUFFER, CORNING MOPSO
- K771605 — CREATINE KINASE ISOENZYME SUBSTRATE SET
- K771324 — 3-(N-MORPHOLINS)-PROPANE SULFONIC ACID
- K760591 — SIGMA PROCEDURE NO. 745 - EP.REAGENT SY
Data sourced from openFDA. This site is unofficial and independent of the FDA.