Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Randox Laboratories, Ltd. — Predicate Candidate Screening
116 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
111 daysmedian FDA review time
421 days90th percentile
116clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| DEN240035 | ConcizuTrace™ ELISA | Randox Laboratories, Ltd. | 2025-05-22 | 325 | 0 |
| K230890 | ISE Electrodes | Randox Laboratories, Ltd. | 2023-09-08 | 161 | 0 |
| K182042 | Randox Calcium (Ca) | Randox Laboratories, Ltd. | 2018-10-23 | 85 | 0 |
| K162200 | Randox RX Daytona Plus Magnesium (MG) | Randox Laboratories, Ltd. | 2017-04-28 | 266 | 0 |
| K152085 | Liquid CO2-2 (LCO2-2) | Randox Laboratories, Ltd. | 2016-02-24 | 212 | 0 |
| K153435 | Direct HDL Cholesterol (HDL) | Randox Laboratories, Ltd. | 2016-01-08 | 42 | 0 |
| K150654 | Cholesterol | Randox Laboratories, Ltd. | 2015-09-29 | 200 | 0 |
| K131554 | RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTAT | Randox Laboratories, Ltd. | 2014-01-09 | 224 | 2 |
| K123977 | RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR | Randox Laboratories, Ltd. | 2013-11-21 | 330 | 0 |
| K132156 | RANDOX CSF CONTROLS LEVELS 2 AND 3 | Randox Laboratories, Ltd. | 2013-10-23 | 104 | 0 |
| K132090 | BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL | Randox Laboratories, Ltd. | 2013-08-08 | 27 | 0 |
| K131999 | HBA1C CONTROL, LEVEL 1 AND LEVEL 2 | Randox Laboratories, Ltd. | 2013-07-26 | 28 | 0 |
| K131776 | ALDOLASE CONTROLS LEVEL 2, AND ALDOLASE CONTROL LEVEL 3 | Randox Laboratories, Ltd. | 2013-07-18 | 31 | 0 |
| K121603 | RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 | Randox Laboratories, Ltd. | 2012-11-20 | 228 | 0 |
| K113720 | RANDOX MATERNAL CONTROL, LEVELS 1, 2 AND 3 | Randox Laboratories, Ltd. | 2012-09-20 | 276 | 0 |
| K121746 | RANDOX MICROALBUMIN CONTROL LEVEL 1 AND CONTROL LEVEL 2 (LIQ | Randox Laboratories, Ltd. | 2012-07-11 | 27 | 0 |
| K121588 | RANDOX CYSTATIN C CONTROL LEVEL 2 RANDOX CYSTATIN C CONTROL | Randox Laboratories, Ltd. | 2012-06-20 | 20 | 0 |
| K113751 | RANDOX COCAINE METABOLITE | Randox Laboratories, Ltd. | 2012-05-08 | 139 | 0 |
| K112337 | RANDOX LIQUID IMMUNOASSAY PREMIUM CONTROLS, LEVEL 1, LEVEL2, | Randox Laboratories, Ltd. | 2011-12-01 | 108 | 0 |
| K102346 | RANDOX DIGOXIN ASSAY | Randox Laboratories, Ltd. | 2011-10-14 | 421 | 0 |
| K110904 | RANDOX LIQUID URINE CONTROL LEVELS 2 AND 3 | Randox Laboratories, Ltd. | 2011-09-30 | 183 | 2 |
| K092268 | RANDOX BARITURATES ASSAY | Randox Laboratories, Ltd. | 2011-05-25 | 666 | 0 |
| K092266 | RANDOX METHAMPHETAMINE ASSAY | Randox Laboratories, Ltd. | 2011-05-09 | 650 | 0 |
| K092269 | CANNABINOID ASSAY AND THE RANDOX CANNABINOID CALIBRATOR/ CON | Randox Laboratories, Ltd. | 2011-04-08 | 619 | 0 |
| K092275 | RANDOX ECSTASY (MDMA) ASSAY | Randox Laboratories, Ltd. | 2011-03-01 | 581 | 0 |
| K092272 | RANDOX METHADONE ASSAY | Randox Laboratories, Ltd. | 2010-11-18 | 478 | 0 |
| K092258 | RANDOX METABOLITE (EDDP) ASSAY | Randox Laboratories, Ltd. | 2010-11-09 | 469 | 0 |
| K092273 | RANDOX ETHANOL ASSAY | Randox Laboratories, Ltd. | 2010-11-01 | 461 | 0 |
| K092274 | RANDOX BENZODIAZEPINE ASSAY | Randox Laboratories, Ltd. | 2010-10-15 | 444 | 0 |
| K061056 | RANDOX LIQUID PROTEIN CALIBRATOR | Randox Laboratories, Ltd. | 2006-07-20 | 94 | 2 |
| K052914 | RX IMOLA | Randox Laboratories, Ltd. | 2006-03-31 | 168 | 1 |
| K053153 | RANDOX CALIBRATION SERUM | Randox Laboratories, Ltd. | 2006-01-13 | 64 | 4 |
| K050179 | RANDOX BENZODIAZEPINE CLASS ASSAY | Randox Laboratories, Ltd. | 2005-05-17 | 111 | 0 |
| K043268 | SODIUM TEST KIT AND ELETROLYTE CAL 1 AND 2 | Randox Laboratories, Ltd. | 2005-02-15 | 81 | 0 |
| K043266 | RANDOX URINE CONTROLS | Randox Laboratories, Ltd. | 2005-02-15 | 81 | 0 |
| K043267 | POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2 | Randox Laboratories, Ltd. | 2005-02-10 | 76 | 0 |
| K043071 | RANDOX PHENCYCLIDINE ASSAY | Randox Laboratories, Ltd. | 2005-01-27 | 80 | 0 |
| K041142 | RANDOX CANNABINOIDS ASSSAY | Randox Laboratories, Ltd. | 2004-11-23 | 207 | 0 |
| K041143 | RANDOX BARBITURATE ASSAY | Randox Laboratories, Ltd. | 2004-11-05 | 189 | 0 |
| K041144 | RANDOX OPIATES ASSAY | Randox Laboratories, Ltd. | 2004-11-03 | 187 | 0 |
| K040379 | RANDOX IMMUNOASSAY CONTROL | Randox Laboratories, Ltd. | 2004-06-16 | 120 | 0 |
| K033884 | RANDOX AMIKACIN | Randox Laboratories, Ltd. | 2004-06-09 | 177 | 0 |
| K040350 | RANDOX AMPHETAMINE CLASS ASSAY | Randox Laboratories, Ltd. | 2004-05-12 | 90 | 0 |
| K040570 | RANDOX METHADONE ASSAY | Randox Laboratories, Ltd. | 2004-05-10 | 67 | 0 |
| K040351 | RANDOX LIQUID CRP CONTROLS | Randox Laboratories, Ltd. | 2004-03-12 | 29 | 0 |
| K033278 | RANDOX URIC ACID | Randox Laboratories, Ltd. | 2004-02-27 | 140 | 0 |
| K030360 | RANDOX EVIDENCE | Randox Laboratories, Ltd. | 2003-12-23 | 323 | 0 |
| K024014 | RANDOX RX DAYTONA | Randox Laboratories, Ltd. | 2003-12-04 | 365 | 1 |
| K031608 | RANDOX LIQUID PROTEIN CALIBRATOR | Randox Laboratories, Ltd. | 2003-08-08 | 78 | 0 |
| K030873 | RANDOX AMMONIA | Randox Laboratories, Ltd. | 2003-05-12 | 53 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda