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Diagnostic Chemicals, Ltd. (Usa) · Predicate Candidate Screening
77 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
43 daysmedian FDA review time
122 days90th percentile
77clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K022538 | IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790 | Diagnostic Chemicals, Ltd. (Usa) | 2002-08-23 | 22 | 0 |
| K974874 | BILIRUBIN-SL (TOTAL) ASSAY | Diagnostic Chemicals, Ltd. (Usa) | 1998-02-12 | 45 | 0 |
| K932556 | AMMONIA ASSAY CAT. NO. 200-02 | Diagnostic Chemicals, Ltd. (Usa) | 1994-08-02 | 433 | 0 |
| K932766 | HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM) | Diagnostic Chemicals, Ltd. (Usa) | 1993-12-10 | 185 | 0 |
| K932555 | DC-LINEATE CAT. NO. SE-091 | Diagnostic Chemicals, Ltd. (Usa) | 1993-08-19 | 85 | 0 |
| K925877 | DC-UIBC-CAL | Diagnostic Chemicals, Ltd. (Usa) | 1993-03-18 | 119 | 0 |
| K912825 | MAGNESIUM ASSAY KIT, CAT.# 100-12 | Diagnostic Chemicals, Ltd. (Usa) | 1991-07-26 | 30 | 0 |
| K895964 | DCL SYPHILIS-M CATALOG NO. 600-80 | Diagnostic Chemicals, Ltd. (Usa) | 1991-01-08 | 454 | 0 |
| K895965 | DCL - SYPHILIS-G ASSAY CATALOG NO. 600-70 | Diagnostic Chemicals, Ltd. (Usa) | 1990-12-26 | 441 | 0 |
| K904660 | ENZYMATIC BILIRUBIN (TOTAL), CATALOGUE NO. 202-14 | Diagnostic Chemicals, Ltd. (Usa) | 1990-11-20 | 36 | 0 |
| K901510 | ENZYMATIC THEOPHYLLINE REAGENT, #500-82 | Diagnostic Chemicals, Ltd. (Usa) | 1990-06-12 | 74 | 0 |
| K895873 | CALCIUM, CATALOGUE NUMBER140-20 | Diagnostic Chemicals, Ltd. (Usa) | 1989-12-12 | 69 | 0 |
| K885097 | ACETAMINOPHEN (ENZYMATIC RATE), NUMBER 502-13 | Diagnostic Chemicals, Ltd. (Usa) | 1989-01-11 | 33 | 0 |
| K883148 | IMMUKNOW-CHECK HCG ASSAY KIT, CAT. #900-40 | Diagnostic Chemicals, Ltd. (Usa) | 1988-12-05 | 132 | 0 |
| K880868 | CARBON DIOXIDE ASSAY KIT (ENZYMATIC) 201-18/202-18 | Diagnostic Chemicals, Ltd. (Usa) | 1988-11-01 | 245 | 0 |
| K882258 | DC-LIQUICAL CATALOGUE #SE-030 | Diagnostic Chemicals, Ltd. (Usa) | 1988-08-30 | 91 | 0 |
| K882259 | DC-BILITROL CATALOGUE # SE-021, SE-022, SE-023 | Diagnostic Chemicals, Ltd. (Usa) | 1988-07-21 | 51 | 0 |
| K880692 | ASPARTATE AMINOTRANSFERASE ASSAY KIT (IFCC) | Diagnostic Chemicals, Ltd. (Usa) | 1988-05-27 | 95 | 0 |
| K880866 | CARBON DIOXIDE ASSAY KIT(ENZY. SINGLE) 203-10 | Diagnostic Chemicals, Ltd. (Usa) | 1988-04-28 | 58 | 0 |
| K880867 | AMYLASE 405 CATALOG NUMBER 301-34 | Diagnostic Chemicals, Ltd. (Usa) | 1988-04-19 | 49 | 0 |
| K881054 | CALCIUM, CATALOGUE NUMBER 122-20 | Diagnostic Chemicals, Ltd. (Usa) | 1988-04-18 | 38 | 0 |
| K875207 | ALBUMIN CAT. # 201-03 | Diagnostic Chemicals, Ltd. (Usa) | 1988-04-18 | 122 | 0 |
| K875211 | GLUCOSE (TRINDER) CAT. # 220-32 | Diagnostic Chemicals, Ltd. (Usa) | 1988-04-18 | 122 | 0 |
| K875208 | CHLORIDE CAT. # 152-17 | Diagnostic Chemicals, Ltd. (Usa) | 1988-04-18 | 122 | 0 |
| K874496 | CALCIUM ASSAY KIT, NUMBER 120-19 | Diagnostic Chemicals, Ltd. (Usa) | 1988-02-11 | 101 | 0 |
| K875210 | ALKALINE PHOSPHATASE CAT. # 306-22, 306-23 | Diagnostic Chemicals, Ltd. (Usa) | 1988-02-02 | 46 | 0 |
| K875206 | LACTATE DEHYDROGENASE CAT. # 320-68, 320-69 | Diagnostic Chemicals, Ltd. (Usa) | 1988-02-02 | 46 | 0 |
| K875209 | ACID PHOSPHATASE (KINETIC) CAT. # 320-06 | Diagnostic Chemicals, Ltd. (Usa) | 1988-02-01 | 45 | 0 |
| K874284 | SHOT-GUN ISOLAT PROCED/MEASUREMENT CK-MB IN SERUM | Diagnostic Chemicals, Ltd. (Usa) | 1988-01-21 | 99 | 0 |
| K874772 | DC-TROL LEVEL 1 OR 2 | Diagnostic Chemicals, Ltd. (Usa) | 1988-01-05 | 47 | 0 |
| K870336 | SALICYLATE ASSAY KIT, CATALOGUE NUMBER 501-71 | Diagnostic Chemicals, Ltd. (Usa) | 1987-02-20 | 23 | 0 |
| K862834 | MODEL 115-16 PHOSPHORUS (UV) ASSAY KIT | Diagnostic Chemicals, Ltd. (Usa) | 1986-08-19 | 25 | 0 |
| K862833 | MODEL 303-47/303-48 ALANINE AMINOTRANSFERASE KIT | Diagnostic Chemicals, Ltd. (Usa) | 1986-08-19 | 25 | 0 |
| K862832 | MODEL 303-42/303-43 ASPARTATE AMINOTRANSFERASE KIT | Diagnostic Chemicals, Ltd. (Usa) | 1986-08-12 | 18 | 0 |
| K861095 | BILIRUBIN ASSAY KIT (TOTAL), CATA. NUMBER 202-04 | Diagnostic Chemicals, Ltd. (Usa) | 1986-04-21 | 28 | 0 |
| K861094 | BILIRUBIN ASSAY KIT (DIRECT), CATA. NUMBER 202-02 | Diagnostic Chemicals, Ltd. (Usa) | 1986-04-21 | 28 | 0 |
| K860625 | GLUCOSE HK-60 ASSAY KIT CAT. #201-39 | Diagnostic Chemicals, Ltd. (Usa) | 1986-03-17 | 26 | 0 |
| K853102 | UREASE & GLUTAMATE DEHYDROGENASE, UREA NITROGEN | Diagnostic Chemicals, Ltd. (Usa) | 1985-08-02 | 10 | 0 |
| K852753 | DC LIQUITROL LEVEL 1 & 2 | Diagnostic Chemicals, Ltd. (Usa) | 1985-08-02 | 35 | 0 |
| K852595 | DC-3 FLUIDS PACK, DC-5 FLUIDS PACK | Diagnostic Chemicals, Ltd. (Usa) | 1985-07-12 | 23 | 0 |
| K852058 | CHLORIDE ASSAY KIT | Diagnostic Chemicals, Ltd. (Usa) | 1985-07-12 | 64 | 0 |
| K852636 | X-AMYLASE ASSAY KIT | Diagnostic Chemicals, Ltd. (Usa) | 1985-07-12 | 22 | 0 |
| K852594 | DC-LIP, CATALOGUE NUMBER SE-020 | Diagnostic Chemicals, Ltd. (Usa) | 1985-07-12 | 23 | 0 |
| K850788 | GLUTAMYLTRANSFERASE ASSAY KIT | Diagnostic Chemicals, Ltd. (Usa) | 1985-03-19 | 21 | 0 |
| K842158 | SALICYLATE ASSAY KIT | Diagnostic Chemicals, Ltd. (Usa) | 1984-10-22 | 145 | 0 |
| K843536 | TRIGLYCERIDE ASSAY KIT GPO-CP | Diagnostic Chemicals, Ltd. (Usa) | 1984-10-11 | 34 | 0 |
| K842873 | STANDARDS & ACCESSORIES FOR NOVA INSTRU | Diagnostic Chemicals, Ltd. (Usa) | 1984-10-05 | 74 | 0 |
| K843379 | VMA ASSAY KIT | Diagnostic Chemicals, Ltd. (Usa) | 1984-09-28 | 31 | 0 |
| K843377 | CREATININE ASSAY KIT | Diagnostic Chemicals, Ltd. (Usa) | 1984-09-28 | 31 | 0 |
| K843380 | ACID PHOSPHATASE ASSAY KIT | Diagnostic Chemicals, Ltd. (Usa) | 1984-09-20 | 23 | 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