Panels › Clinical Chemistry › Product code JHX · Class 2
Fluorometric Method, Cpk Or Isoenzymes
Regulation 862.1215
0510(k)s in 12 months (48 all time)
0recalls in 12 months (15 all time)
15recalls that name a 510(k)
Top companies in JHX
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 25, 2025 | Siemens Healthcare Diagnostics Inc Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma. Open, Classified |
JHX | K051650 |
| Apr 30, 2018 | Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc PATHFAST Myoglobin II reagent cartridge
Catalog Number: PF1111-K
PATHFAST NTproBNP is a product for in-vitro diagnostic use with the in vitro diagnostic system PATHFAST for the quantitative measureme Terminated |
JHX | K081360 |
| Mar 5, 2018 | Tosoh Bioscience Inc ST-AIA PACK CK-MB; Part Number: 025269
Assay, Cardiac Marker Terminated |
JHX | K913298 |
| Jun 22, 2016 | Siemens Healthcare Diagnostics Inc Stratus CS STAT Fluorometric Analyzer-microprocessor-controlled instrument
that measures certain analytes in body fluids for in vitro diagnostic use. Assays include ~hCG, CRP, CKMB, cTNI, D-Dimer, Myo Terminated |
JHX | K984067 |
| Jan 7, 2016 | Siemens Healthcare Diagnostics Inc Siemens Acute Care CKMB DilPak- an in vitro diagnostic product intended to be used in conjunction with the Acute Care CKMB TestPak
Catalog Number: CCKMB-D
SMN: 10445070 Terminated |
JHX | K051650 |
| Jan 7, 2016 | Siemens Healthcare Diagnostics Inc Siemens Acute Care CKMB TestPak- in vitro diagnostic test for the measurement of the MB isoenzyme of creatine kinase (ATP: Creatine NPhosphostransferase, E. C. No. 2.7 .3.2) in heparinized plasma
Cat Terminated |
JHX | K051650 |
| Mar 21, 2012 | Siemens Healthcare Diagnostics IMMULITE 2500 CK-MB L5KCP --- Catalog number: L5KCP2 (200 tests), L5KCP6 (600 tests) --- Test code: RCK Color: Orange.
For in vitro diagnostic use with the IMMULITE 2500 Analyzer --- for the quantita Terminated |
JHX | K034055 |
| Mar 21, 2012 | Siemens Healthcare Diagnostics IMMULITE 2000/IMMULITE 2000 XPi CK-MB L2KMB --- Catalog number: L2KMB2 (200 tests), L2KMB6 (600 tests) --- Test code: CMB Color: Dark Blue.
For in vitro diagnostic use with the IMMULITE 2000 Analyzer Terminated |
JHX | K004002 |
| Mar 21, 2012 | Siemens Healthcare Diagnostics IMMULITE/IMMULITE Turbo 1000 CK-MB LSKCP --- Catalog number: LSKCP1 (100 tests), LSKCP5 (500 tests) --- Test code: RCK Color: Orange.
For in vitro diagnostic use with the IMMULITE and IMMULITE 1000 A Terminated |
JHX | K022118 |
| Mar 21, 2012 | Siemens Healthcare Diagnostics IMMULITE/IMMULITE 1000 CK-MB LKMB --- Catalog number: LKMB1 (100 tests), LKMB5 (500 tests) --- Test code: CMB Color: Dark Blue.
For in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyze Terminated |
JHX | K004002 |
| Nov 10, 2010 | Siemens Healthcare Diagnostics, Inc. Stratus(R) CS Rotors, catalog number CROTOR, lot number NH42-251-09
Intended use: Stratus(R) rotors is intended for the separation of whole blood samples for analysis on the Stratus(R) CS analyzer Terminated |
JHX | K984067 |
| Jan 28, 2009 | Dade Behring, Inc. Stratus CS Acute Care Troponin I TestPak, Catalog number CCTNI, in vitro diagnostic. Terminated |
JHX | K051650 |
| May 19, 2006 | Dade Behring , Inc. Stratus CS STAT Fluorometric Analyzer CKMB DilPak (CCKMB-D) in vitro diagnostic. Terminated |
JHX | K981099 |
| May 19, 2006 | Dade Behring , Inc. Stratus CS STAT Fluorometric Analyzer CKMB TestPak (CCKMB) in vitro diagnostic. Terminated |
JHX | K984067 |
| Jan 6, 2004 | Ortho-Clinical Diagnostics Vitros Immunodiagnostic Products CK-MB REAGENT PACK, REF 189 6836, 100 coated wells per pack. Firm on the label: Ortho-Clinical Diagnostics, Amersham, UK. Terminated |
JHX | K993068 |
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