Medical Device Manufacturer · CA , Charlottetown, P.E.I.

Diagnostic Chemicals , Ltd.

66 submissions · 66 cleared · Since 1994
66
Total
66
Cleared
0
Denied

Diagnostic Chemicals , Ltd. — FDA 510(k) Submissions

Diagnostic Chemicals , Ltd. has submitted 66 FDA 510(k) premarket notifications since 1994, of which 66 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Enzymatic, Carbon-dioxide, Colorimetry, Acetaminophen, Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method, Urease And Glutamic Dehydrogenase, Urea Nitrogen, Calibrator, Multi-analyte Mixture . Use the specialty filter in the sidebar to narrow results.

66 devices
1–25 of 66
ENZYMATIC CREATININE ASSAY (265 SERIES)
K070383 · JFY Enzymatic Method, Creatinine · Chemistry
Jun 2007 133d
MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7
K063208 · JGJ Photometric Method,... · Chemistry
Jan 2007 88d
CRP-ADVANCE ASSAY, MODELS 250-20, 250-25
K060139 · DCK C-reactive Protein,... · Chemistry
Apr 2006 99d
CRP-ADVANCE MULTI CALIBRATOR SET, MODEL SE-250
K060140 · JIT Calibrator, Secondary · Chemistry
Apr 2006 95d
CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91
K051757 · CJY Azo Dye, Calcium · Chemistry
Nov 2005 134d
DCL MICROALBUMIN ASSAY, MODEL 252-20
K051191 · DCF Albumin, Antigen,... · Chemistry
Jul 2005 56d
ACETAMINOPHEN-SL ASSAY
K042330 · LDP Colorimetry, Acetaminophen · Toxicology
Jan 2005 133d
SALICYLATE-SL ASSAY
K042329 · DKJ Colorimetry, Salicylate · Toxicology
Dec 2004 122d
MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299-80 AND 299-12
K042362 · KHS Enzymatic, Carbon-dioxide · Chemistry
Dec 2004 118d
HDL/LDL-ADVANCE CALIBRATOR, CAT. NO. SE-278
K041926 · JIX Calibrator, Multi-analyte... · Chemistry
Nov 2004 127d
LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40
K041927 · MRR System, Test, Low... · Chemistry
Nov 2004 127d
HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B
K041928 · LBS Ldl & Vldl Precipitation,... · Chemistry
Nov 2004 127d
MICROALBUMIN MULTI-CALIBRATOR SET
K042243 · JIX Calibrator, Multi-analyte... · Chemistry
Oct 2004 46d
DC-ACETA/SAL CONTROLS
K041666 · DIF Drug Mixture Control... · Toxicology
Aug 2004 60d
AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10
K033921 · JIF Enzymatic Method, Ammonia · Chemistry
Mar 2004 83d
GLUCOSE-SL-C ASSAY, MODEL 257-30
K023739 · CFR Hexokinase, Glucose · Chemistry
Jan 2003 71d
BILIRUBIN-SL (TOTAL) ASSAY, MODEL 284-10/30
K023330 · CIG Diazo Colorimetry, Bilirubin · Chemistry
Dec 2002 68d
IRON-PC-SL ASSAY MODEL # 151-10, 151-26
K020816 · JIY Photometric Method, Iron... · Chemistry
May 2002 62d
DC-UIBC-CO2-CAL, MODEL SE-153
K013178 · JIX Calibrator, Multi-analyte... · Chemistry
Dec 2001 85d
ALKALINE PHOSPHATASE-SL ASSAY, MODELS 328-17 AND 328-30
K003093 · CJE Nitrophenylphosphate,... · Chemistry
Nov 2000 55d
CARBON DIOXIDE-L3K-C ASSAY, MODELS 288-30 AND 288-80
K002354 · KHS Enzymatic, Carbon-dioxide · Toxicology
Sep 2000 55d
UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/30
K002694 · CDQ Urease And Glutamic... · Chemistry
Sep 2000 17d
ETHANOL-L3K ASSAY, MODELS 273-30, 273-17, 273-10
K001286 · DIC Alcohol Dehydrogenase,... · Toxicology
Jun 2000 60d
AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 263-30
K001285 · JIF Enzymatic Method, Ammonia · Chemistry
Jun 2000 42d
CREATININE-S ASSAY, MODEL 221-30, 221-50, 221-17
K000055 · CGX Alkaline Picrate,... · Chemistry
Feb 2000 42d
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