501 results
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30ms
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Sources: EU EUDAMED, US FDA
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Classification: FDA Class 1
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ARCHITECT ESTRADIOL MASTERCHEK, MODEL # 6C22-05
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ACCU-CHEK II LOW AND HIGH GLUCOSE CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
HEMOCUE GLUCOLIN
FDA 510(k)
FDA Class 1
·Clinical Chemistry
TNT TROPONIN T
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MODIFICATION TO ROCHE ELECSYS FOLATE II CALCHECK II
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LIFESCAN ONETOUCH SELECT / ULTRA / VITA GLUCOSE CONTROL SOLUTION
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DADE TRU-LIQUID BILIRUBIN CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ADVIA CENTAUR VITAMIN B12 MASTER CURVE MATERIAL, TOTAL HCG MASTER CURVE MATERIAL, AND TESTOSTERONE MASTER CURVE MATERIAL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CHEMSPEX(TM) AMMONIA CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000 IGFBP-3 Calibration Verification Material
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ALDOLASE CONTROLS LEVEL 2, AND ALDOLASE CONTROL LEVEL 3
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CONTREX PLUS LOW CONTROL SOLUTION
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DAC-CEL DIAGNATAL HCG STANDARDS RD49
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LD-1 ISOENZYME CONTROL (HUMAN) LEVEL 1 & 2
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Multichem A1c
FDA 510(k)
FDA Class 1
·Clinical Chemistry
IMMULITE 2000 PSA CALIBRATION VERIFICATION MATERIAL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ELECSYS CK-MB CALCHECK 5
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL I
FDA 510(k)
FDA Class 1
·Clinical Chemistry
OPUS T4 CONTROLS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ELECSYS RUBELLA IGGA CALCHECK 5
FDA 510(k)
FDA Class 1
·Clinical Chemistry