Company ยท US
Electro-Nucleonics Laboratories, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1988. Name variants (Inc, Corp, punctuation) are merged.
41510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 3 |
| JQW | Station, Pipetting And Diluting, For Clinical Use | 3 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 2 |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 2 |
| KLS | Enzyme Immunoassay, Theophylline | 2 |
| CDO | Acid, Uric, Uricase (U.V.) | 1 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 1 |
| CJA | Amyloclastic, Amylase | 1 |
| CZP | Iga, Antigen, Antiserum, Control | 1 |
| DAO | Igm (Mu Chain Specific), Antigen, Antiserum, Control | 1 |
| DEW | Igg, Antigen, Antiserum, Control | 1 |
| DIP | Enzyme Immunoassay, Diphenylhydantoin | 1 |
| GGW | Test, Time, Partial Thromboplastin | 1 |
| GNP | Antiserum, Cf, Epstein-Barr Virus | 1 |
| GOK | Antisera, Hai (Including Hai Control), Rubella | 1 |
| GPW | Antigen, Cf, Psittacosis (Chlamydia Group) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 24, 1988 | K873925 | VIRGO(TM) MEASLES IGG ELISA Electro-Nucleonics Laboratories, Inc. | LJB |
| Oct 19, 1987 | K873617 | GEMSTAR II SYSTEM Electro-Nucleonics Laboratories, Inc. | JJE |
| Oct 9, 1987 | K873416 | MULTI-ACCESS REAGENT DISPENSER Electro-Nucleonics Laboratories, Inc. | JQW |
| Sep 11, 1987 | K873358 | GEMENI URIC ACID U.V. Electro-Nucleonics Laboratories, Inc. | CDO |
| Sep 9, 1987 | K873088 | VIRGO(TM) RUBELLA IGG ELISA Electro-Nucleonics Laboratories, Inc. | LFX |
| Jul 30, 1987 | K871905 | TOXOPLASMA GONDII IGG ELISA Electro-Nucleonics Laboratories, Inc. | LGD |
| Apr 22, 1987 | K870928 | CHOLESTEROL (TOTAL) ANALYSIS PRODUCTS Electro-Nucleonics Laboratories, Inc. | CHH |
| Nov 13, 1986 | K863874 | LIPASE HYDROLYSIS/GLYCEROL KINASE, TRIGLYCERIDES Electro-Nucleonics Laboratories, Inc. | CDT |
| Sep 9, 1986 | K862640 | AMYLASE LTS Electro-Nucleonics Laboratories, Inc. | CJA |
| Sep 4, 1985 | K853372 | GEMSTAR IPA THEOPHYLLINE TEST KIT Electro-Nucleonics Laboratories, Inc. | KLS |
| Aug 23, 1985 | K853373 | DELTA TROL I & II Electro-Nucleonics Laboratories, Inc. | JJT |
| Apr 29, 1985 | K851267 | GEMENI AST-LTS REAGENTS Electro-Nucleonics Laboratories, Inc. | CIT |
| Jan 3, 1985 | K843779 | AUTOLOADER II Electro-Nucleonics Laboratories, Inc. | JQW |
| Nov 27, 1984 | K844065 | ENI BLOOD UREA NITROGEN REAGENT Electro-Nucleonics Laboratories, Inc. | CDQ |
| Apr 25, 1984 | K841127 | VIRGO REAGENTS INDIRECT FLUORSCENT Electro-Nucleonics Laboratories, Inc. | DHN |
| Nov 3, 1983 | K832744 | STARLYTE Electro-Nucleonics Laboratories, Inc. | JGS |
| Sep 20, 1983 | K832648 | ACCLAIM Electro-Nucleonics Laboratories, Inc. | JJE |
| Sep 20, 1983 | K831504 | HERPES IDENT. & TYPING TEST HITT Electro-Nucleonics Laboratories, Inc. | GQL |
| Sep 12, 1983 | K832639 | ALT -LTS Electro-Nucleonics Laboratories, Inc. | CKA |
| Sep 12, 1983 | K831965 | CREATINE KINASE REAGENT CK LTS Electro-Nucleonics Laboratories, Inc. | CGS |
| Aug 11, 1983 | K831924 | ANTIBODY TO RESPIRATORY SYNCYTIAL VIRUS Electro-Nucleonics Laboratories, Inc. | LKT |
| Dec 3, 1982 | K822826 | ANTIBODY TO MUMPS VIRUS IFA TEST Electro-Nucleonics Laboratories, Inc. | GRA |
| Jul 30, 1982 | K821249 | ENI ANTIBODY TO MEASLES(RUBEOLA) VIRUS Electro-Nucleonics Laboratories, Inc. | GRE |
| Jul 13, 1982 | K821335 | GEMSTAR SYSTEM Electro-Nucleonics Laboratories, Inc. | JJE |
| Jun 10, 1982 | K821544 | DETECTION OF THEOPHYLLINE Electro-Nucleonics Laboratories, Inc. | KLS |
| Jun 3, 1982 | K821543 | IPA FOR DETECTION OF PHENOBARBITAL Electro-Nucleonics Laboratories, Inc. | LFN |
| Jun 3, 1982 | K821542 | VIRGO IMMUNO-PRECIPITATION ASSAY TOBRA Electro-Nucleonics Laboratories, Inc. | LCR |
| Jul 23, 1981 | K811570 | ANTIBODY TO CHLAMYDIA TRACHOMATIS Electro-Nucleonics Laboratories, Inc. | GPW |
| Jul 10, 1981 | K811745 | VIRGO IPA FOR DETECTION OF PHENYTOIN Electro-Nucleonics Laboratories, Inc. | DIP |
| Jul 10, 1981 | K811744 | VIRGO IPA FOR DETECTION OF GENTAMICIN Electro-Nucleonics Laboratories, Inc. | LCD |
| Jun 18, 1981 | K811525 | FLEXIGRAM AUTO LOADER SYSTEM Electro-Nucleonics Laboratories, Inc. | JJG |
| May 5, 1981 | K810860 | ENI ANTIBODY TO EPSTEIN-BARR VIRUS Electro-Nucleonics Laboratories, Inc. | GNP |
| Jul 14, 1980 | K800787 | ANTIBODY TO VARICELLA-ZOSTER VIRUS Electro-Nucleonics Laboratories, Inc. | GGW |
| May 28, 1980 | K801030 | RIAUSE AUTO PROCESSOR Electro-Nucleonics Laboratories, Inc. | JQW |
| Apr 24, 1980 | K800451 | GEMENI IGG ASSAY Electro-Nucleonics Laboratories, Inc. | DEW |
| Apr 24, 1980 | K800450 | GEMENI IGM ASSAY Electro-Nucleonics Laboratories, Inc. | DAO |
| Mar 19, 1980 | K792635 | ANTIBODY TO RUBELLA VIRUS Electro-Nucleonics Laboratories, Inc. | GOK |
| Mar 12, 1980 | K800449 | GEMENI IGA ASSAY Electro-Nucleonics Laboratories, Inc. | CZP |
| Sep 7, 1979 | K791058 | ANTIBODY TO HERPESVIRUS HOMINIS Electro-Nucleonics Laboratories, Inc. | GQO |
| Oct 18, 1977 | K771376 | IFA ANTI-NDNA Electro-Nucleonics Laboratories, Inc. | DHN |
| Dec 29, 1976 | K761269 | GEMENI GPT (ALT) ASSAY Electro-Nucleonics Laboratories, Inc. | CKA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||