Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nuclear Diagnostics, Inc. — Predicate Candidate Screening
22 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
36 daysmedian FDA review time
147 days90th percentile
22clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K923917 | ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAY | Nuclear Diagnostics, Inc. | 1994-02-25 | 569 | 0 |
| K932406 | NUCLITRYP(TM)(I125)-HUMAN PANCREA CATH TRY RAD KIT | Nuclear Diagnostics, Inc. | 1993-12-02 | 203 | 0 |
| K872177 | TIPSEP-CORTISOL RIA DIAGNOSTIC KIT | Nuclear Diagnostics, Inc. | 1987-06-17 | 9 | 0 |
| K862312 | ENZLIPASE, ENZYMATIC LIPASE KIT | Nuclear Diagnostics, Inc. | 1986-09-26 | 100 | 0 |
| K860472 | NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESS | Nuclear Diagnostics, Inc. | 1986-07-03 | 147 | 0 |
| K861735 | TIPSEP-TBG ASSAY | Nuclear Diagnostics, Inc. | 1986-06-13 | 38 | 0 |
| K852291 | TIPSEP DIGOXIN RIA | Nuclear Diagnostics, Inc. | 1985-06-25 | 27 | 0 |
| K833713 | SERUM THYROTROPIN ASSAY KIT, TIPSEP- | Nuclear Diagnostics, Inc. | 1983-12-29 | 69 | 0 |
| K823860 | NUCLIPASE (I125) PANCREATIC LIPASE | Nuclear Diagnostics, Inc. | 1983-04-18 | 117 | 0 |
| K811558 | TSH-P.E.G. | Nuclear Diagnostics, Inc. | 1981-06-18 | 16 | 0 |
| K810906 | TRI-LEVEL NDI CONTROL | Nuclear Diagnostics, Inc. | 1981-04-14 | 11 | 0 |
| K802886 | NUCLI-PAP TM-(I125)-PAP RADIOIMMUNOAS- | Nuclear Diagnostics, Inc. | 1981-01-28 | 72 | 0 |
| K792599 | TIPSEP-T4(RIA) T4 RADIOIMMUNOASSAY | Nuclear Diagnostics, Inc. | 1980-01-16 | 29 | 0 |
| K792484 | TIPSEP-T3U TRIIODOTHYRONINE UPTAKE | Nuclear Diagnostics, Inc. | 1979-12-27 | 24 | 0 |
| K790133 | SPINSEP-FE59 | Nuclear Diagnostics, Inc. | 1979-03-02 | 38 | 0 |
| K781560 | RIA DIAG. TEST KIT FOR INDEXING THYROX. | Nuclear Diagnostics, Inc. | 1978-10-17 | 36 | 0 |
| K780644 | RADIOASSAY FOR TOTAL SERUM THYROXINE | Nuclear Diagnostics, Inc. | 1978-04-28 | 11 | 0 |
| K780486 | STIKSEP-T3 KIT | Nuclear Diagnostics, Inc. | 1978-04-28 | 32 | 0 |
| K780423 | STIKSEP-T4 RIA KIT | Nuclear Diagnostics, Inc. | 1978-03-30 | 14 | 0 |
| K780292 | TRIA-PEG RIA DIAG. KIT | Nuclear Diagnostics, Inc. | 1978-03-02 | 9 | 0 |
| K771854 | SPINSEP-T3 | Nuclear Diagnostics, Inc. | 1977-12-22 | 85 | 0 |
| K771341 | SPINSEP-TBG | Nuclear Diagnostics, Inc. | 1977-08-10 | 22 | 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