Diagnostic Systems
Mchenry, IL, US
Diagnostic Systems appears in FDA device records in Mchenry, IL. FDA records list 14 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 14
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 14 510(k) clearances for Diagnostic Systems between 1983 and 1991. The busiest year on record is 1985, with 4. The most recent is 1991, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 2 |
| 1985 | 4 |
| 1986 | 1 |
| 1988 | 3 |
| 1989 | 3 |
| 1991 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K905146 | OLYMPUS URINE PH | JQY | Substantially Equivalent | |
| K893691 | EMDS CREATINE KINASE ITEM NIMBER 65411 | CGS | Substantially Equivalent | |
| K893692 | EMDS ASPARTATE AMINOTRANSFERASE ITEM NUMBER 65405 | CIT | Substantially Equivalent | |
| K893966 | HDL PRECIPITATING REAGENT | LBR | Substantially Equivalent | |
| K884993 | VISUAL BLOOD GLUCOSE TEST SYSTEM | CGA | Substantially Equivalent | |
| K881116 | EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641 | KLR | Substantially Equivalent | |
| K880787 | EASY-TEST LACTIC ACID (LA) | KHP | Substantially Equivalent | |
| K862403 | EMDS ANTIEPILEPTIC DRUG CALIBRATORS ITEM #67630/95 | DKB | Substantially Equivalent | |
| K854784 | ABSORBANCE (ABS) TEST PAK | JIT | Substantially Equivalent | |
| K853699 | EASY ANALYZER & EASY-TEST REAGENT | JJE | Substantially Equivalent | |
| K853533 | ABSORBANCE TEST SOLUTION | JIT | Substantially Equivalent | |
| K853532 | ALCOHOL CALIBRATORS | DNN | Substantially Equivalent | |
| K830816 | DSL 1900 | CGI | Substantially Equivalent | |
| K830700 | MMH PTH RIA KIT | CEW | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KHPAcid, Lactic, Enzymatic Method
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- JITCalibrator, Secondary
- DKBCalibrators, Drug Mixture
- DNNCalibrators, Ethyl Alcohol
- KLREnzyme Immunoassay, Lidocaine
- CGAGlucose Oxidase, Glucose
- LBRLdl & Vldl Precipitation, Hdl
- CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- JQYPh Meter
- CGIRadioimmunoassay, Estriol
- CEWRadioimmunoassay, Parathyroid Hormone
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain