Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Diagnostic Chemicals , Ltd. — Predicate Candidate Screening
66 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
66 daysmedian FDA review time
148 days90th percentile
66clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K070383 | ENZYMATIC CREATININE ASSAY (265 SERIES) | Diagnostic Chemicals , Ltd. | 2007-06-22 | 133 | 2 |
| K063208 | MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7 | Diagnostic Chemicals , Ltd. | 2007-01-19 | 88 | 0 |
| K060139 | CRP-ADVANCE ASSAY, MODELS 250-20, 250-25 | Diagnostic Chemicals , Ltd. | 2006-04-28 | 99 | 0 |
| K060140 | CRP-ADVANCE MULTI CALIBRATOR SET, MODEL SE-250 | Diagnostic Chemicals , Ltd. | 2006-04-24 | 95 | 0 |
| K051757 | CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91 | Diagnostic Chemicals , Ltd. | 2005-11-10 | 134 | 0 |
| K051191 | DCL MICROALBUMIN ASSAY, MODEL 252-20 | Diagnostic Chemicals , Ltd. | 2005-07-05 | 56 | 0 |
| K042330 | ACETAMINOPHEN-SL ASSAY | Diagnostic Chemicals , Ltd. | 2005-01-07 | 133 | 2 |
| K042362 | MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, | Diagnostic Chemicals , Ltd. | 2004-12-27 | 118 | 0 |
| K042329 | SALICYLATE-SL ASSAY | Diagnostic Chemicals , Ltd. | 2004-12-27 | 122 | 1 |
| K041926 | HDL/LDL-ADVANCE CALIBRATOR, CAT. NO. SE-278 | Diagnostic Chemicals , Ltd. | 2004-11-23 | 127 | 0 |
| K041927 | LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40 | Diagnostic Chemicals , Ltd. | 2004-11-23 | 127 | 0 |
| K041928 | HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B | Diagnostic Chemicals , Ltd. | 2004-11-23 | 127 | 0 |
| K042243 | MICROALBUMIN MULTI-CALIBRATOR SET | Diagnostic Chemicals , Ltd. | 2004-10-04 | 46 | 1 |
| K041666 | DC-ACETA/SAL CONTROLS | Diagnostic Chemicals , Ltd. | 2004-08-17 | 60 | 0 |
| K033921 | AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10 | Diagnostic Chemicals , Ltd. | 2004-03-10 | 83 | 1 |
| K023739 | GLUCOSE-SL-C ASSAY, MODEL 257-30 | Diagnostic Chemicals , Ltd. | 2003-01-17 | 71 | 0 |
| K023330 | BILIRUBIN-SL (TOTAL) ASSAY, MODEL 284-10/30 | Diagnostic Chemicals , Ltd. | 2002-12-11 | 68 | 0 |
| K020816 | IRON-PC-SL ASSAY MODEL # 151-10, 151-26 | Diagnostic Chemicals , Ltd. | 2002-05-14 | 62 | 0 |
| K013178 | DC-UIBC-CO2-CAL, MODEL SE-153 | Diagnostic Chemicals , Ltd. | 2001-12-18 | 85 | 0 |
| K003093 | ALKALINE PHOSPHATASE-SL ASSAY, MODELS 328-17 AND 328-30 | Diagnostic Chemicals , Ltd. | 2000-11-27 | 55 | 0 |
| K002354 | CARBON DIOXIDE-L3K-C ASSAY, MODELS 288-30 AND 288-80 | Diagnostic Chemicals , Ltd. | 2000-09-26 | 55 | 0 |
| K002694 | UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/30 | Diagnostic Chemicals , Ltd. | 2000-09-15 | 17 | 0 |
| K001286 | ETHANOL-L3K ASSAY, MODELS 273-30, 273-17, 273-10 | Diagnostic Chemicals , Ltd. | 2000-06-20 | 60 | 0 |
| K001285 | AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 26 | Diagnostic Chemicals , Ltd. | 2000-06-02 | 42 | 0 |
| K000055 | CREATININE-S ASSAY, MODEL 221-30, 221-50, 221-17 | Diagnostic Chemicals , Ltd. | 2000-02-18 | 42 | 0 |
| K994035 | IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15 | Diagnostic Chemicals , Ltd. | 2000-02-01 | 64 | 0 |
| K993920 | ETHANOL-L3K ASSAY, CATALOGUE NUMBER 273-30, 273-17 | Diagnostic Chemicals , Ltd. | 2000-01-18 | 61 | 0 |
| K993178 | UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/10/30/50 | Diagnostic Chemicals , Ltd. | 1999-10-18 | 25 | 0 |
| K990754 | CARBON DIOXIDE - L3K ASSAY, CATALOGUE NUMBER 299-30/40/50 | Diagnostic Chemicals , Ltd. | 1999-04-20 | 43 | 0 |
| K983019 | CARBON DIOXIDE-SL ASSAY, CAT # 253-01 | Diagnostic Chemicals , Ltd. | 1998-09-14 | 14 | 0 |
| K981872 | SALICYLATE-SL ASSAY CATALOGUE NUMBER 511-20,511-40 | Diagnostic Chemicals , Ltd. | 1998-06-29 | 32 | 0 |
| K981609 | BILIRUBIN-SL (DIRECT) ASSAY CATALOGUE NUMBER 247-10,247-30 | Diagnostic Chemicals , Ltd. | 1998-06-03 | 29 | 0 |
| K981059 | ACETAMINOPHEN-SL ASSAY, CATALOGUE # 505-10, 505-30. | Diagnostic Chemicals , Ltd. | 1998-05-12 | 50 | 0 |
| K980772 | HDL-CHOLESTEROL PRECIPITATING REAGENT, CATALOGUE NUMBER 205- | Diagnostic Chemicals , Ltd. | 1998-04-27 | 66 | 0 |
| K980770 | HDL UNI-PAKS (PTA), CATALOGUE NUMBER 215-51 | Diagnostic Chemicals , Ltd. | 1998-04-21 | 60 | 0 |
| K974002 | ETHANOL-SL ASSAY, CATALOGUE NUMBER 240-12 | Diagnostic Chemicals , Ltd. | 1998-04-01 | 162 | 0 |
| K973999 | CREATINE KINASE-SL ASSAY, CATALOGUE NUMBER 326-10, 326-30 | Diagnostic Chemicals , Ltd. | 1998-03-11 | 141 | 0 |
| K980031 | ACETAMINOPHEN ASSAY (ACE), CATALOGUE NUMBER 503-10 | Diagnostic Chemicals , Ltd. | 1998-03-03 | 57 | 0 |
| K980032 | SALICYLATE ASSAY (ACE), CATALOGUE NUMBER 501-71 | Diagnostic Chemicals , Ltd. | 1998-03-02 | 56 | 0 |
| K973108 | TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50 | Diagnostic Chemicals , Ltd. | 1998-03-02 | 195 | 0 |
| K980316 | ALKALINE PHOSPHATASE-SL ASSAY CATALOGUE NUMBER 309-10, 309-3 | Diagnostic Chemicals , Ltd. | 1998-02-12 | 16 | 0 |
| K974858 | PHOSPHORUS-SL ASSAY, CATALOGUE NUMBER 117-10, 117-30 | Diagnostic Chemicals , Ltd. | 1998-01-30 | 32 | 0 |
| K974859 | LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327 | Diagnostic Chemicals , Ltd. | 1998-01-22 | 24 | 0 |
| K974053 | AMYLASE-SL ASSAY CATALOGUE NUMBER 341-10 | Diagnostic Chemicals , Ltd. | 1997-12-08 | 42 | 0 |
| K974003 | ALANINE AMINOTRANSFERASE-SL ASSAY CATALOGUE NUMBER 318-10, 3 | Diagnostic Chemicals , Ltd. | 1997-12-05 | 45 | 0 |
| K973931 | UREA-SL ASSAY CATALOGUE NUMBER 239-10, 239-30 | Diagnostic Chemicals , Ltd. | 1997-11-24 | 40 | 0 |
| K974001 | ASPARTATE AMINOTRANSFERASE-SL ASSAY, CATALOGUE NUMBER 319-10 | Diagnostic Chemicals , Ltd. | 1997-11-13 | 23 | 0 |
| K974000 | Y-GLUTAMYLTRANSFERASE-SL ASSAY , CATALOGE NUMBER 324-10, 324 | Diagnostic Chemicals , Ltd. | 1997-11-04 | 14 | 0 |
| K973933 | SERUM IRON-SL ASSAY, CATALOGUE NUMBERS 157-10, 157-30 | Diagnostic Chemicals , Ltd. | 1997-11-04 | 20 | 0 |
| K972337 | DCLARE IMMUNODIP STICKFOR MICROALBUMINURIA | Diagnostic Chemicals , Ltd. | 1997-08-08 | 46 | 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