ClearanceBrief
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)
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Top companies in JHX

DateFirm and productCodeLinked 510(k)
Apr 25, 2025Siemens Healthcare Diagnostics Inc
Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma.
Open, Classified
JHXK051650
Apr 30, 2018Polymedco, 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
JHXK081360
Mar 5, 2018Tosoh Bioscience Inc
ST-AIA PACK CK-MB; Part Number: 025269 Assay, Cardiac Marker
Terminated
JHXK913298
Jun 22, 2016Siemens 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
JHXK984067
Jan 7, 2016Siemens 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
JHXK051650
Jan 7, 2016Siemens 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
JHXK051650
Mar 21, 2012Siemens 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
JHXK034055
Mar 21, 2012Siemens 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
JHXK004002
Mar 21, 2012Siemens 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
JHXK022118
Mar 21, 2012Siemens 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
JHXK004002
Nov 10, 2010Siemens 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
JHXK984067
Jan 28, 2009Dade Behring, Inc.
Stratus CS Acute Care Troponin I TestPak, Catalog number CCTNI, in vitro diagnostic.
Terminated
JHXK051650
May 19, 2006Dade Behring , Inc.
Stratus CS STAT Fluorometric Analyzer CKMB DilPak (CCKMB-D) in vitro diagnostic.
Terminated
JHXK981099
May 19, 2006Dade Behring , Inc.
Stratus CS STAT Fluorometric Analyzer CKMB TestPak (CCKMB) in vitro diagnostic.
Terminated
JHXK984067
Jan 6, 2004Ortho-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
JHXK993068

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