Medical Device Manufacturer · US , Mchenry , IL

Diagnostic Systems

14 submissions · 14 cleared · Since 1983
14
Total
14
Cleared
0
Denied

Diagnostic Systems — FDA 510(k) Submissions

Diagnostic Systems has submitted 14 FDA 510(k) premarket notifications since 1983, of which 14 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Calibrator, Secondary, Calibrators, Ethyl Alcohol, Analyzer, Chemistry (photometric, Discrete), For Clinical Use, Calibrators, Drug Mixture, Acid, Lactic, Enzymatic Method . Use the specialty filter in the sidebar to narrow results.

14 devices
1–14 of 14
OLYMPUS URINE PH
K905146 · JQY Ph Meter · Chemistry
Feb 1991 81d
EMDS CREATINE KINASE ITEM NIMBER 65411
K893691 · CGS Nad Reduction/nadh... · Chemistry
Aug 1989 107d
EMDS ASPARTATE AMINOTRANSFERASE ITEM NUMBER 65405
K893692 · CIT Nadh Oxidation/nad... · Chemistry
Aug 1989 97d
HDL PRECIPITATING REAGENT
K893966 · LBR Ldl & Vldl Precipitation,... · Chemistry
Jul 1989 53d
VISUAL BLOOD GLUCOSE TEST SYSTEM
K884993 · CGA Glucose Oxidase, Glucose · Chemistry
Dec 1988 28d
EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641
K881116 · KLR Enzyme Immunoassay,... · Toxicology
Jun 1988 97d
EASY-TEST LACTIC ACID (LA)
K880787 · KHP Acid, Lactic, Enzymatic... · Chemistry
Mar 1988 18d
EMDS ANTIEPILEPTIC DRUG CALIBRATORS ITEM #67630/95
K862403 · DKB Calibrators, Drug Mixture · Toxicology
Jul 1986 15d
ABSORBANCE (ABS) TEST PAK
K854784 · JIT Calibrator, Secondary · Chemistry
Dec 1985 20d
EASY ANALYZER & EASY-TEST REAGENT
K853699 · JJE Analyzer, Chemistry... · Chemistry
Sep 1985 21d
ALCOHOL CALIBRATORS
K853532 · DNN Calibrators, Ethyl Alcohol · Chemistry
Sep 1985 24d
ABSORBANCE TEST SOLUTION
K853533 · JIT Calibrator, Secondary · Chemistry
Sep 1985 24d
DSL 1900
K830816 · CGI Radioimmunoassay, Estriol · Chemistry
Apr 1983 28d
MMH PTH RIA KIT
K830700 · CEW Radioimmunoassay,... · Chemistry
Apr 1983 30d
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