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Electro-Nucleonics Laboratories, Inc. — Predicate Candidate Screening
41 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
44 daysmedian FDA review time
91 days90th percentile
41clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K873925 | VIRGO(TM) MEASLES IGG ELISA | Electro-Nucleonics Laboratories, Inc. | 1988-02-24 | 152 | 0 |
| K873617 | GEMSTAR II SYSTEM | Electro-Nucleonics Laboratories, Inc. | 1987-10-19 | 41 | 0 |
| K873416 | MULTI-ACCESS REAGENT DISPENSER | Electro-Nucleonics Laboratories, Inc. | 1987-10-09 | 45 | 0 |
| K873358 | GEMENI URIC ACID U.V. | Electro-Nucleonics Laboratories, Inc. | 1987-09-11 | 21 | 0 |
| K873088 | VIRGO(TM) RUBELLA IGG ELISA | Electro-Nucleonics Laboratories, Inc. | 1987-09-09 | 35 | 0 |
| K871905 | TOXOPLASMA GONDII IGG ELISA | Electro-Nucleonics Laboratories, Inc. | 1987-07-30 | 76 | 0 |
| K870928 | CHOLESTEROL (TOTAL) ANALYSIS PRODUCTS | Electro-Nucleonics Laboratories, Inc. | 1987-04-22 | 44 | 0 |
| K863874 | LIPASE HYDROLYSIS/GLYCEROL KINASE, TRIGLYCERIDES | Electro-Nucleonics Laboratories, Inc. | 1986-11-13 | 41 | 0 |
| K862640 | AMYLASE LTS | Electro-Nucleonics Laboratories, Inc. | 1986-09-09 | 61 | 0 |
| K853372 | GEMSTAR IPA THEOPHYLLINE TEST KIT | Electro-Nucleonics Laboratories, Inc. | 1985-09-04 | 23 | 0 |
| K853373 | DELTA TROL I & II | Electro-Nucleonics Laboratories, Inc. | 1985-08-23 | 11 | 0 |
| K851267 | GEMENI AST-LTS REAGENTS | Electro-Nucleonics Laboratories, Inc. | 1985-04-29 | 31 | 0 |
| K843779 | AUTOLOADER II | Electro-Nucleonics Laboratories, Inc. | 1985-01-03 | 100 | 0 |
| K844065 | ENI BLOOD UREA NITROGEN REAGENT | Electro-Nucleonics Laboratories, Inc. | 1984-11-27 | 40 | 0 |
| K841127 | VIRGO REAGENTS INDIRECT FLUORSCENT | Electro-Nucleonics Laboratories, Inc. | 1984-04-25 | 40 | 0 |
| K832744 | STARLYTE | Electro-Nucleonics Laboratories, Inc. | 1983-11-03 | 80 | 0 |
| K832648 | ACCLAIM | Electro-Nucleonics Laboratories, Inc. | 1983-09-20 | 46 | 0 |
| K831504 | HERPES IDENT. & TYPING TEST HITT | Electro-Nucleonics Laboratories, Inc. | 1983-09-20 | 132 | 0 |
| K831965 | CREATINE KINASE REAGENT CK LTS | Electro-Nucleonics Laboratories, Inc. | 1983-09-12 | 84 | 0 |
| K832639 | ALT -LTS | Electro-Nucleonics Laboratories, Inc. | 1983-09-12 | 39 | 0 |
| K831924 | ANTIBODY TO RESPIRATORY SYNCYTIAL VIRUS | Electro-Nucleonics Laboratories, Inc. | 1983-08-11 | 57 | 0 |
| K822826 | ANTIBODY TO MUMPS VIRUS IFA TEST | Electro-Nucleonics Laboratories, Inc. | 1982-12-03 | 73 | 0 |
| K821249 | ENI ANTIBODY TO MEASLES(RUBEOLA) VIRUS | Electro-Nucleonics Laboratories, Inc. | 1982-07-30 | 91 | 0 |
| K821335 | GEMSTAR SYSTEM | Electro-Nucleonics Laboratories, Inc. | 1982-07-13 | 69 | 0 |
| K821544 | DETECTION OF THEOPHYLLINE | Electro-Nucleonics Laboratories, Inc. | 1982-06-10 | 17 | 0 |
| K821542 | VIRGO IMMUNO-PRECIPITATION ASSAY TOBRA | Electro-Nucleonics Laboratories, Inc. | 1982-06-03 | 10 | 0 |
| K821543 | IPA FOR DETECTION OF PHENOBARBITAL | Electro-Nucleonics Laboratories, Inc. | 1982-06-03 | 10 | 0 |
| K811570 | ANTIBODY TO CHLAMYDIA TRACHOMATIS | Electro-Nucleonics Laboratories, Inc. | 1981-07-23 | 49 | 0 |
| K811745 | VIRGO IPA FOR DETECTION OF PHENYTOIN | Electro-Nucleonics Laboratories, Inc. | 1981-07-10 | 21 | 0 |
| K811744 | VIRGO IPA FOR DETECTION OF GENTAMICIN | Electro-Nucleonics Laboratories, Inc. | 1981-07-10 | 21 | 0 |
| K811525 | FLEXIGRAM AUTO LOADER SYSTEM | Electro-Nucleonics Laboratories, Inc. | 1981-06-18 | 20 | 0 |
| K810860 | ENI ANTIBODY TO EPSTEIN-BARR VIRUS | Electro-Nucleonics Laboratories, Inc. | 1981-05-05 | 36 | 0 |
| K800787 | ANTIBODY TO VARICELLA-ZOSTER VIRUS | Electro-Nucleonics Laboratories, Inc. | 1980-07-14 | 97 | 0 |
| K801030 | RIAUSE AUTO PROCESSOR | Electro-Nucleonics Laboratories, Inc. | 1980-05-28 | 27 | 0 |
| K800450 | GEMENI IGM ASSAY | Electro-Nucleonics Laboratories, Inc. | 1980-04-24 | 55 | 0 |
| K800451 | GEMENI IGG ASSAY | Electro-Nucleonics Laboratories, Inc. | 1980-04-24 | 55 | 0 |
| K792635 | ANTIBODY TO RUBELLA VIRUS | Electro-Nucleonics Laboratories, Inc. | 1980-03-19 | 91 | 0 |
| K800449 | GEMENI IGA ASSAY | Electro-Nucleonics Laboratories, Inc. | 1980-03-12 | 12 | 0 |
| K791058 | ANTIBODY TO HERPESVIRUS HOMINIS | Electro-Nucleonics Laboratories, Inc. | 1979-09-07 | 91 | 0 |
| K771376 | IFA ANTI-NDNA | Electro-Nucleonics Laboratories, Inc. | 1977-10-18 | 85 | 0 |
| K761269 | GEMENI GPT (ALT) ASSAY | Electro-Nucleonics Laboratories, Inc. | 1976-12-29 | 13 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda