Electro-Nucleonics Laboratories, Inc.
Mchenry, IL, US
Electro-Nucleonics Laboratories, Inc. appears in FDA device records in Mchenry, IL. FDA records list 41 510(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
- 41
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 41 510(k) clearances for Electro-Nucleonics Laboratories, Inc. between 1976 and 1988. The busiest year on record is 1980, with 6. The most recent is 1988, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1977 | 1 |
| 1979 | 1 |
| 1980 | 6 |
| 1981 | 5 |
| 1982 | 6 |
| 1983 | 6 |
| 1984 | 2 |
| 1985 | 4 |
| 1986 | 2 |
| 1987 | 6 |
| 1988 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K873925 | VIRGO(TM) MEASLES IGG ELISA | LJB | Substantially Equivalent | |
| K873617 | GEMSTAR II SYSTEM | JJE | Substantially Equivalent | |
| K873416 | MULTI-ACCESS REAGENT DISPENSER | JQW | Substantially Equivalent | |
| K873358 | GEMENI URIC ACID U.V. | CDO | Substantially Equivalent | |
| K873088 | VIRGO(TM) RUBELLA IGG ELISA | LFX | Substantially Equivalent | |
| K871905 | TOXOPLASMA GONDII IGG ELISA | LGD | Substantially Equivalent | |
| K870928 | CHOLESTEROL (TOTAL) ANALYSIS PRODUCTS | CHH | Substantially Equivalent | |
| K863874 | LIPASE HYDROLYSIS/GLYCEROL KINASE, TRIGLYCERIDES | CDT | Substantially Equivalent | |
| K862640 | AMYLASE LTS | CJA | Substantially Equivalent | |
| K853372 | GEMSTAR IPA THEOPHYLLINE TEST KIT | KLS | Substantially Equivalent | |
| K853373 | DELTA TROL I & II | JJT | Substantially Equivalent | |
| K851267 | GEMENI AST-LTS REAGENTS | CIT | Substantially Equivalent | |
| K843779 | AUTOLOADER II | JQW | Substantially Equivalent | |
| K844065 | ENI BLOOD UREA NITROGEN REAGENT | CDQ | Substantially Equivalent | |
| K841127 | VIRGO REAGENTS INDIRECT FLUORSCENT | DHN | Substantially Equivalent | |
| K832744 | STARLYTE | JGS | Substantially Equivalent | |
| K832648 | ACCLAIM | JJE | Substantially Equivalent | |
| K831504 | HERPES IDENT. & TYPING TEST HITT | GQL | Substantially Equivalent | |
| K832639 | ALT -LTS | CKA | Substantially Equivalent | |
| K831965 | CREATINE KINASE REAGENT CK LTS | CGS | Substantially Equivalent | |
| K831924 | ANTIBODY TO RESPIRATORY SYNCYTIAL VIRUS | LKT | Substantially Equivalent | |
| K822826 | ANTIBODY TO MUMPS VIRUS IFA TEST | GRA | Substantially Equivalent | |
| K821249 | ENI ANTIBODY TO MEASLES(RUBEOLA) VIRUS | GRE | Substantially Equivalent | |
| K821335 | GEMSTAR SYSTEM | JJE | Substantially Equivalent | |
| K821544 | DETECTION OF THEOPHYLLINE | KLS | Substantially Equivalent | |
| K821543 | IPA FOR DETECTION OF PHENOBARBITAL | LFN | Substantially Equivalent | |
| K821542 | VIRGO IMMUNO-PRECIPITATION ASSAY TOBRA | LCR | Substantially Equivalent | |
| K811570 | ANTIBODY TO CHLAMYDIA TRACHOMATIS | GPW | Substantially Equivalent | |
| K811745 | VIRGO IPA FOR DETECTION OF PHENYTOIN | DIP | Substantially Equivalent | |
| K811744 | VIRGO IPA FOR DETECTION OF GENTAMICIN | LCD | Substantially Equivalent | |
| K811525 | FLEXIGRAM AUTO LOADER SYSTEM | JJG | Substantially Equivalent | |
| K810860 | ENI ANTIBODY TO EPSTEIN-BARR VIRUS | GNP | Substantially Equivalent | |
| K800787 | ANTIBODY TO VARICELLA-ZOSTER VIRUS | GGW | Substantially Equivalent | |
| K801030 | RIAUSE AUTO PROCESSOR | JQW | Substantially Equivalent | |
| K800451 | GEMENI IGG ASSAY | DEW | Substantially Equivalent | |
| K800450 | GEMENI IGM ASSAY | DAO | Substantially Equivalent | |
| K792635 | ANTIBODY TO RUBELLA VIRUS | GOK | Substantially Equivalent | |
| K800449 | GEMENI IGA ASSAY | CZP | Substantially Equivalent | |
| K791058 | ANTIBODY TO HERPESVIRUS HOMINIS | GQO | Substantially Equivalent | |
| K771376 | IFA ANTI-NDNA | DHN | Substantially Equivalent | |
| K761269 | GEMENI GPT (ALT) ASSAY | CKA | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CDOAcid, Uric, Uricase (U.V.)
- CJAAmyloclastic, Amylase
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- JJGAnalyzer, Chemistry, Centrifugal, For Clinical Use
- GPWAntigen, Cf, Psittacosis (Chlamydia Group)
- DHNAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
- GQOAntisera, Cf, Herpesvirus Hominis 1,2
- GQLAntisera, Fluorescent, Herpesvirus Hominis 1,2
- GOKAntisera, Hai (Including Hai Control), Rubella
- GNPAntiserum, Cf, Epstein-Barr Virus
- GRAAntiserum, Fluorescent, Mumps Virus
- GREAntiserum, Fluorescent, Rubeola
- JGSElectrode, Ion Specific, Sodium
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- JJTEnzyme Controls (Assayed And Unassayed)
- DIPEnzyme Immunoassay, Diphenylhydantoin
- LCDEnzyme Immunoassay, Gentamicin
- KLSEnzyme Immunoassay, Theophylline
- LFXEnzyme Linked Immunoabsorbent Assay, Rubella
- LJBEnzyme Linked Immunoabsorbent Assay, Rubeola Igg
- LGDEnzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
- LCRFluorescent Immunoassay, Tobramycin
- CZPIga, Antigen, Antiserum, Control
- DEWIgg, Antigen, Antiserum, Control
- DAOIgm (Mu Chain Specific), Antigen, Antiserum, Control
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- CKANadh Oxidation/Nad Reduction, Alt/Sgpt
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- LFNNephelometric Inhibition Immunoassay, Phenobarbital
- LKTRespiratory Syncytial Virus, Antigen, Antibody, Ifa
- JQWStation, Pipetting And Diluting, For Clinical Use
- GGWTest, Time, Partial Thromboplastin
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain