Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Immuno Nuclear Corp. — Predicate Candidate Screening
30 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
38 daysmedian FDA review time
124 days90th percentile
30clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K863743 | BIOTECH'S IGE IMMUNO RESPONSE TEST ISOTOPE UNIT | Immuno Nuclear Corp. | 1986-12-15 | 82 | 0 |
| K863973 | ELM ALLERGEN DISC | Immuno Nuclear Corp. | 1986-12-01 | 48 | 0 |
| K863844 | IMMUNO BIOTECH'S LAMB'S QUARTERS ALLERGEN DISC | Immuno Nuclear Corp. | 1986-10-29 | 28 | 0 |
| K863123 | IMMUNO BIOTECH MUGWART ALLERGEN DISC | Immuno Nuclear Corp. | 1986-10-01 | 48 | 0 |
| K863098 | MEADOW FESCUE ALLERGEN DISC | Immuno Nuclear Corp. | 1986-09-15 | 33 | 0 |
| K862266 | MAPLE ALLERGEN DISC | Immuno Nuclear Corp. | 1986-08-19 | 67 | 0 |
| K862265 | COTTONWOOD ALLERGEN DISC | Immuno Nuclear Corp. | 1986-08-15 | 63 | 0 |
| K862939 | ORCHARD GRASS ALLERGEN DISC | Immuno Nuclear Corp. | 1986-08-15 | 11 | 0 |
| K862176 | RUSSIAN THISTLE ALLERGEN DISC | Immuno Nuclear Corp. | 1986-08-15 | 67 | 0 |
| K862938 | JUNE GRASS ALLERGEN DISC | Immuno Nuclear Corp. | 1986-08-15 | 11 | 0 |
| K862174 | TIMOTHY ALLERGEN DISC | Immuno Nuclear Corp. | 1986-08-06 | 58 | 0 |
| K862173 | PERENNIAL RYE ALLERGEN DISC | Immuno Nuclear Corp. | 1986-07-03 | 24 | 0 |
| K862264 | ENGLISH PLAINTAIN ALLERGEN DISC | Immuno Nuclear Corp. | 1986-07-03 | 20 | 0 |
| K862175 | WHITE OAK ALLERGEN DISC | Immuno Nuclear Corp. | 1986-06-20 | 11 | 0 |
| K854756 | SHORT RAGWEED ALLERGEN DISC | Immuno Nuclear Corp. | 1986-05-15 | 169 | 0 |
| K850892 | SOMATOMEDIN C BY RADIOIMMUNOASSAY | Immuno Nuclear Corp. | 1985-06-06 | 94 | 0 |
| K850882 | ACTH II BY RADIOIMMUNOASSAY | Immuno Nuclear Corp. | 1985-03-21 | 17 | 0 |
| K844135 | PLASMA CYCLIC ADENOSINE MONOPHOSPHATE BY RADIOIMMU | Immuno Nuclear Corp. | 1985-03-05 | 133 | 0 |
| K842079 | GASTRIN 34 HORMONE BY RADIOUMMUNOASSAY | Immuno Nuclear Corp. | 1984-06-26 | 34 | 0 |
| K830664 | HUMAN INTRACT PARATHYROID HORMONE BY | Immuno Nuclear Corp. | 1983-05-09 | 67 | 0 |
| K823504 | CYCLIC ADENOSINE MONOPHOSHATE BY RADIO | Immuno Nuclear Corp. | 1983-01-28 | 65 | 0 |
| K820666 | HUMAN C-PEPTIDE OF INSULIN BY RADIOIMM. | Immuno Nuclear Corp. | 1982-07-13 | 124 | 0 |
| K820228 | MIN-MOLECULE PTH BY RADIOIMMUNOASSAY | Immuno Nuclear Corp. | 1982-03-11 | 43 | 0 |
| K812727 | GASTRIN 1-17 BY RADIOIMMUNOASSAY KIT | Immuno Nuclear Corp. | 1981-11-05 | 38 | 0 |
| K811565 | ACTH RADIOIMMUNOASSAY KIT | Immuno Nuclear Corp. | 1981-06-25 | 21 | 0 |
| K811566 | C-TERMINAL PTH BY RADIOIMMUNOASSAY KIT | Immuno Nuclear Corp. | 1981-06-25 | 21 | 0 |
| K811418 | N-TERMINAL HPTH BY RIA | Immuno Nuclear Corp. | 1981-06-24 | 36 | 0 |
| K803278 | LUTEINIZING HORMONE RADIOIMMUNOASSAY KIT | Immuno Nuclear Corp. | 1981-01-21 | 23 | 0 |
| K803279 | FOLLICE STIMULATING HORMONE-RADIOIMM. KT | Immuno Nuclear Corp. | 1981-01-16 | 18 | 0 |
| K803280 | HUMAN GROWTH HORMONE-RADIOIMM. KIT | Immuno Nuclear Corp. | 1981-01-16 | 18 | 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