Randox Laboratories, Ltd.
FDA 510(k) medical device clearances.
Top product codes for Randox Laboratories, Ltd.
Recent clearances by Randox Laboratories, Ltd.
1–100 of 116- DEN240035 — ConcizuTrace ELISA
- K230890 — ISE Electrodes
- K182042 — Randox Calcium (Ca)
- K162200 — Randox RX Daytona Plus Magnesium (MG)
- K152085 — Liquid CO2-2 (LCO2-2)
- K153435 — Direct HDL Cholesterol (HDL)
- K150654 — Cholesterol
- K131554 — RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENT
- K123977 — RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR
- K132156 — RANDOX CSF CONTROLS LEVELS 2 AND 3
- K132090 — BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2
- K131999 — HBA1C CONTROL, LEVEL 1 AND LEVEL 2
- K131776 — ALDOLASE CONTROLS LEVEL 2, AND ALDOLASE CONTROL LEVEL 3
- K121603 — RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 3
- K113720 — RANDOX MATERNAL CONTROL, LEVELS 1, 2 AND 3
- K121746 — RANDOX MICROALBUMIN CONTROL LEVEL 1 AND CONTROL LEVEL 2 (LIQUID)
- K121588 — RANDOX CYSTATIN C CONTROL LEVEL 2 RANDOX CYSTATIN C CONTROL LEVEL 3
- K113751 — RANDOX COCAINE METABOLITE
- K112337 — RANDOX LIQUID IMMUNOASSAY PREMIUM CONTROLS, LEVEL 1, LEVEL2, LEVEL 3 AND TRI LEVEL
- K102346 — RANDOX DIGOXIN ASSAY
- K110904 — RANDOX LIQUID URINE CONTROL LEVELS 2 AND 3
- K092268 — RANDOX BARITURATES ASSAY
- K092266 — RANDOX METHAMPHETAMINE ASSAY
- K092269 — CANNABINOID ASSAY AND THE RANDOX CANNABINOID CALIBRATOR/ CONTROL SET
- K092275 — RANDOX ECSTASY (MDMA) ASSAY
- K092272 — RANDOX METHADONE ASSAY
- K092258 — RANDOX METABOLITE (EDDP) ASSAY
- K092273 — RANDOX ETHANOL ASSAY
- K092274 — RANDOX BENZODIAZEPINE ASSAY
- K061056 — RANDOX LIQUID PROTEIN CALIBRATOR
- K052914 — RX IMOLA
- K053153 — RANDOX CALIBRATION SERUM
- K050179 — RANDOX BENZODIAZEPINE CLASS ASSAY
- K043266 — RANDOX URINE CONTROLS
- K043268 — SODIUM TEST KIT AND ELETROLYTE CAL 1 AND 2
- K043267 — POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2
- K043071 — RANDOX PHENCYCLIDINE ASSAY
- K041142 — RANDOX CANNABINOIDS ASSSAY
- K041143 — RANDOX BARBITURATE ASSAY
- K041144 — RANDOX OPIATES ASSAY
- K040379 — RANDOX IMMUNOASSAY CONTROL
- K033884 — RANDOX AMIKACIN
- K040350 — RANDOX AMPHETAMINE CLASS ASSAY
- K040570 — RANDOX METHADONE ASSAY
- K040351 — RANDOX LIQUID CRP CONTROLS
- K033278 — RANDOX URIC ACID
- K030360 — RANDOX EVIDENCE
- K024014 — RANDOX RX DAYTONA
- K031608 — RANDOX LIQUID PROTEIN CALIBRATOR
- K030873 — RANDOX AMMONIA
- K023763 — RANDOX FRUCTOSAMINE, FRUCTOSAMINE CALIBRATOR, FRUCTOSAMINE CONTROLS
- K021897 — RANDOX HAEMOGLOBIN A1C
- K022682 — RANDOX C-REACTIVE PROTEIN CALIBRATOR
- K023158 — RANDOX APOLIPOPROTEIN CALIBRATOR
- K022591 — RANDOX LIPID CONTROL
- K011771 — RANDOX THEOPHYLLINE
- K011648 — RANDOX CARBAMAZEPINE
- K011649 — RANDOX VALPROIC ACID
- K012112 — RANDOX DIGITOXIN
- K011393 — RANDOX PHENYTOIN
- K011568 — RANDOX LIPOPROTEIN
- K012978 — RANDOX GENTAMICIN
- K012318 — RANDOX THERAPEUTIC DRUG CALIBRATOR
- K012319 — RANDOX HUMAN ASSSAYED DRUG CONTROL
- K011302 — RANDOX DIGOXIN
- K011303 — RANDOX PHENOBARBITAL
- K010855 — RANDOX IGE
- K010700 — RANDOX MYOGLOBIN
- K003346 — RANDOX GLUCOSE (GOD/PAP)
- K002585 — RANDOX TRANSFERRIN
- K002674 — RANDOX MICROALBUMIN
- K001009 — RANDOX C-REACTIVE PROTEIN
- K000661 — RANDOX PREALBUMIN
- K000375 — RANDOX CALCIUM
- K000662 — RANDOX FERRITIN
- K000483 — RANDOX ALBUMIN
- K000468 — RANDOX COMPLEMENT C4
- K000469 — RANDOX COMPLEMENT C3
- K984494 — RANDOX ALBUMIN
- K982529 — RANDOX DIRECT LDL CHOLESTEROL
- K982341 — DIRECT HDL-CHOLESTROL LIQUID
- K973993 — RANDOX CREATININE
- K974606 — RANDOX MAGNESIUM
- K974607 — RANDOX CALCIUM
- K974605 — RANDOX INORGANIC PHOSPHOROUS
- K974604 — RANDOX IRON
- K973995 — RANDOX BILIRUBIN
- K972220 — RHEUMATOID FACTOR LATEX-ENHANCED IMMUNOTURBIDIMETRIC TEST KIT
- K972608 — RANDOX ASSAYED SPECIFIC PROTEIN CONTROL
- K971825 — PANCREATIC AMYLASE, ETHYLIDENE BLOCKED-PNPG7 ENZYME COLORIMETRIC TEST
- K970735 — BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL
- K970684 — LACTATE DEHYDROGENASE (LD)
- K953210 — GLUCOSE (HEXOKINASE) KIT
- K961169 — RHEUMATOID FACTOR LATEX SLIDE TEST KIT
- K953211 — AMYLASE (ETHYLIDENE PNGPG7) KIT
- K955489 — CALIBRATION SERUM LEVEL 1 & 2
- K951222 — TOTAL PROTEIN (URINE)
- K955794 — IGA IMMUNOTURBIDIMETRIC & CALIBRATOR
- K955797 — IGM IMMUNOTRUBIDIMETRIC & CALIBRATOR
- K955798 — IGG IMMUNOTURBIDIMETRIC & CALIBRATOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.