Company ยท CA
Diagnostic Chemicals, Ltd. (Usa)
FDA 510(k) clearances and medical device recalls filed under this name, 1984 to 2007. Name variants (Inc, Corp, punctuation) are merged.
143510(k) clearances (0 in 12 months)
6recalls (0 in 12 months)
6recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CIG | Diazo Colorimetry, Bilirubin | 8 |
| KHS | Enzymatic, Carbon-Dioxide | 7 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 6 |
| DKJ | Colorimetry, Salicylate | 6 |
| JIX | Calibrator, Multi-Analyte Mixture | 5 |
| LDP | Colorimetry, Acetaminophen | 5 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 4 |
| CFR | Hexokinase, Glucose | 4 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 4 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 4 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 4 |
| DIC | Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method | 4 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 3 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 3 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 3 |
| CIC | Cresolphthalein Complexone, Calcium | 3 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 3 |
| JFJ | Catalytic Methods, Amylase | 3 |
| JFY | Enzymatic Method, Creatinine | 3 |
| JGJ | Photometric Method, Magnesium | 3 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 22, 2007 | K070383 | ENZYMATIC CREATININE ASSAY (265 SERIES) Diagnostic Chemicals , Ltd., CA | JFY |
| Jan 19, 2007 | K063208 | MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7 Diagnostic Chemicals , Ltd., CA | JGJ |
| Apr 28, 2006 | K060139 | CRP-ADVANCE ASSAY, MODELS 250-20, 250-25 Diagnostic Chemicals , Ltd., CA | DCK |
| Apr 24, 2006 | K060140 | CRP-ADVANCE MULTI CALIBRATOR SET, MODEL SE-250 Diagnostic Chemicals , Ltd., CA | JIT |
| Nov 10, 2005 | K051757 | CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91 Diagnostic Chemicals , Ltd., CA | CJY |
| Jul 5, 2005 | K051191 | DCL MICROALBUMIN ASSAY, MODEL 252-20 Diagnostic Chemicals , Ltd., CA | DCF |
| Jan 7, 2005 | K042330 | ACETAMINOPHEN-SL ASSAY Diagnostic Chemicals , Ltd., CA | LDP |
| Dec 27, 2004 | K042362 | MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299-80 AND 299-12 Diagnostic Chemicals , Ltd., CA | KHS |
| Dec 27, 2004 | K042329 | SALICYLATE-SL ASSAY Diagnostic Chemicals , Ltd., CA | DKJ |
| Nov 23, 2004 | K041928 | HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B Diagnostic Chemicals , Ltd., CA | LBS |
| Nov 23, 2004 | K041927 | LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40 Diagnostic Chemicals , Ltd., CA | MRR |
| Nov 23, 2004 | K041926 | HDL/LDL-ADVANCE CALIBRATOR, CAT. NO. SE-278 Diagnostic Chemicals , Ltd., CA | JIX |
| Oct 4, 2004 | K042243 | MICROALBUMIN MULTI-CALIBRATOR SET Diagnostic Chemicals , Ltd., CA | JIX |
| Aug 17, 2004 | K041666 | DC-ACETA/SAL CONTROLS Diagnostic Chemicals , Ltd., CA | DIF |
| Mar 10, 2004 | K033921 | AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10 Diagnostic Chemicals , Ltd., CA | JIF |
| Jan 17, 2003 | K023739 | GLUCOSE-SL-C ASSAY, MODEL 257-30 Diagnostic Chemicals , Ltd., CA | CFR |
| Dec 11, 2002 | K023330 | BILIRUBIN-SL (TOTAL) ASSAY, MODEL 284-10/30 Diagnostic Chemicals , Ltd., CA | CIG |
| Aug 23, 2002 | K022538 | IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25 Diagnostic Chemicals, Ltd. (Usa) | JIR |
| May 14, 2002 | K020816 | IRON-PC-SL ASSAY MODEL # 151-10, 151-26 Diagnostic Chemicals , Ltd., CA | JIY |
| Dec 18, 2001 | K013178 | DC-UIBC-CO2-CAL, MODEL SE-153 Diagnostic Chemicals , Ltd., CA | JIX |
| Nov 27, 2000 | K003093 | ALKALINE PHOSPHATASE-SL ASSAY, MODELS 328-17 AND 328-30 Diagnostic Chemicals , Ltd., CA | CJE |
| Sep 26, 2000 | K002354 | CARBON DIOXIDE-L3K-C ASSAY, MODELS 288-30 AND 288-80 Diagnostic Chemicals , Ltd., CA | KHS |
| Sep 15, 2000 | K002694 | UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/30 Diagnostic Chemicals , Ltd., CA | CDQ |
| Jun 20, 2000 | K001286 | ETHANOL-L3K ASSAY, MODELS 273-30, 273-17, 273-10 Diagnostic Chemicals , Ltd., CA | DIC |
| Jun 2, 2000 | K001285 | AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 263-30 Diagnostic Chemicals , Ltd., CA | JIF |
| Feb 18, 2000 | K000055 | CREATININE-S ASSAY, MODEL 221-30, 221-50, 221-17 Diagnostic Chemicals , Ltd., CA | CGX |
| Feb 1, 2000 | K994035 | IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15 Diagnostic Chemicals , Ltd., CA | JIR |
| Jan 18, 2000 | K993920 | ETHANOL-L3K ASSAY, CATALOGUE NUMBER 273-30, 273-17 Diagnostic Chemicals , Ltd., CA | DIC |
| Oct 18, 1999 | K993178 | UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/10/30/50 Diagnostic Chemicals , Ltd., CA | CDQ |
| Apr 20, 1999 | K990754 | CARBON DIOXIDE - L3K ASSAY, CATALOGUE NUMBER 299-30/40/50 Diagnostic Chemicals , Ltd., CA | KHS |
| Sep 14, 1998 | K983019 | CARBON DIOXIDE-SL ASSAY, CAT # 253-01 Diagnostic Chemicals , Ltd., CA | KHS |
| Jun 29, 1998 | K981872 | SALICYLATE-SL ASSAY CATALOGUE NUMBER 511-20,511-40 Diagnostic Chemicals , Ltd., CA | DKJ |
| Jun 3, 1998 | K981609 | BILIRUBIN-SL (DIRECT) ASSAY CATALOGUE NUMBER 247-10,247-30 Diagnostic Chemicals , Ltd., CA | CIG |
| May 12, 1998 | K981059 | ACETAMINOPHEN-SL ASSAY, CATALOGUE # 505-10, 505-30. Diagnostic Chemicals , Ltd., CA | LDP |
| Apr 27, 1998 | K980772 | HDL-CHOLESTEROL PRECIPITATING REAGENT, CATALOGUE NUMBER 205-51 Diagnostic Chemicals , Ltd., CA | LBR |
| Apr 21, 1998 | K980770 | HDL UNI-PAKS (PTA), CATALOGUE NUMBER 215-51 Diagnostic Chemicals , Ltd., CA | LBR |
| Apr 1, 1998 | K974002 | ETHANOL-SL ASSAY, CATALOGUE NUMBER 240-12 Diagnostic Chemicals , Ltd., CA | DIC |
| Mar 11, 1998 | K973999 | CREATINE KINASE-SL ASSAY, CATALOGUE NUMBER 326-10, 326-30 Diagnostic Chemicals , Ltd., CA | CGS |
| Mar 3, 1998 | K980031 | ACETAMINOPHEN ASSAY (ACE), CATALOGUE NUMBER 503-10 Diagnostic Chemicals , Ltd., CA | LDP |
| Mar 2, 1998 | K980032 | SALICYLATE ASSAY (ACE), CATALOGUE NUMBER 501-71 Diagnostic Chemicals , Ltd., CA | DKJ |
| Mar 2, 1998 | K973108 | TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50 Diagnostic Chemicals , Ltd., CA | CEK |
| Feb 12, 1998 | K980316 | ALKALINE PHOSPHATASE-SL ASSAY CATALOGUE NUMBER 309-10, 309-30 Diagnostic Chemicals , Ltd., CA | CJE |
| Feb 12, 1998 | K974874 | BILIRUBIN-SL (TOTAL) ASSAY Diagnostic Chemicals, Ltd. (Usa), CA | CIG |
| Jan 30, 1998 | K974858 | PHOSPHORUS-SL ASSAY, CATALOGUE NUMBER 117-10, 117-30 Diagnostic Chemicals , Ltd., CA | CEO |
| Jan 22, 1998 | K974859 | LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30 Diagnostic Chemicals , Ltd., CA | CFJ |
| Dec 8, 1997 | K974053 | AMYLASE-SL ASSAY CATALOGUE NUMBER 341-10 Diagnostic Chemicals , Ltd., CA | JFJ |
| Dec 5, 1997 | K974003 | ALANINE AMINOTRANSFERASE-SL ASSAY CATALOGUE NUMBER 318-10, 318-30 Diagnostic Chemicals , Ltd., CA | CKA |
| Nov 24, 1997 | K973931 | UREA-SL ASSAY CATALOGUE NUMBER 239-10, 239-30 Diagnostic Chemicals , Ltd., CA | CDQ |
| Nov 13, 1997 | K974001 | ASPARTATE AMINOTRANSFERASE-SL ASSAY, CATALOGUE NUMBER 319-10, 319-30 Diagnostic Chemicals , Ltd., CA | CIT |
| Nov 4, 1997 | K974000 | Y-GLUTAMYLTRANSFERASE-SL ASSAY , CATALOGE NUMBER 324-10, 324-30 Diagnostic Chemicals , Ltd., CA | JQB |
Newest 50 of 143.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 16, 2010 | Diagnostic Chemicals, Ltd. Genzyme Diagnostics Total Serum Cholesterol Kit, IVD
Catalog Number: 225-26
Intended use: For the IN VITRO quantitative measurement of total serum cholesterol in serum. Terminated |
CHH | K842160 |
| Sep 30, 2009 | Diagnostic Chemicals, Ltd. DCL (Diagnostic Chemicals Limited) Creatine Start Reagent(R1) Catalog Number: 265-OP. Terminated |
JFY | K070383 |
| Sep 30, 2009 | Diagnostic Chemicals, Ltd. DCL (Diagnostic Chemicals Limited) Creatine Enzyme Reagent (R2) Catalog Number: 265-30.
In-vitro diagnostic device used for the quantitative measurement of creatine in serum, plasma and urine. Terminated |
JFY | K070383 |
| May 13, 2009 | Diagnostic Chemicals, Ltd. Diagnostics Chemical Limited Iron Assay
Catalog Number: 102-25
For the In Vitro quantitative determination of iron in serum. Terminated |
JMO | K961587 |
| Feb 27, 2007 | Diagnostic Chemicals, Ltd. Microalbumin Multi-Calibrator Set, in vitro diagnostic.
Catalog Number: SE-252 Terminated |
JIX | K042243 |
| Jan 23, 2007 | Diagnostic Chemicals, Ltd. Salicylate-SL, in vitro diagnostic, Cat. No.511-20, Lot No. 29892 Terminated |
DKJ | K042329 |