Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nuclear Medical Laboratories, Inc. · Predicate Candidate Screening
24 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
32 daysmedian FDA review time
63 days90th percentile
24clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K852438 | NML TSH IRMA | Nuclear Medical Laboratories, Inc. | 1985-07-12 | 32 | 0 |
| K844583 | TSH-STAT | Nuclear Medical Laboratories, Inc. | 1985-03-05 | 102 | 0 |
| K840466 | NML CORTISOL RIA | Nuclear Medical Laboratories, Inc. | 1984-03-30 | 56 | 0 |
| K840589 | TRI-TUBE RIA | Nuclear Medical Laboratories, Inc. | 1984-03-09 | 29 | 0 |
| K832892 | MODIFIED CHORIO-SHURE | Nuclear Medical Laboratories, Inc. | 1983-10-28 | 63 | 0 |
| K832002 | NML-5010/5020 MULTI-DETECTOR SYSTEM | Nuclear Medical Laboratories, Inc. | 1983-08-08 | 47 | 0 |
| K823679 | NML 6000 CT | Nuclear Medical Laboratories, Inc. | 1983-01-07 | 31 | 0 |
| K823053 | NML-TETRA-TUBE RIA | Nuclear Medical Laboratories, Inc. | 1982-11-10 | 23 | 0 |
| K822298 | DIAGNOSTIC RADIOIMMUNOASSAY FOR QUANTI | Nuclear Medical Laboratories, Inc. | 1982-09-02 | 30 | 0 |
| K820523 | CHORIO-QUANT | Nuclear Medical Laboratories, Inc. | 1982-03-15 | 17 | 0 |
| K812759 | NML CK-MB RIA | Nuclear Medical Laboratories, Inc. | 1981-10-19 | 18 | 0 |
| K810936 | CHORIO-SHURE | Nuclear Medical Laboratories, Inc. | 1981-04-17 | 10 | 0 |
| K810033 | CORTI-SHURE | Nuclear Medical Laboratories, Inc. | 1981-01-21 | 15 | 0 |
| K802120 | HEPA-SHURE -L | Nuclear Medical Laboratories, Inc. | 1980-10-20 | 46 | 0 |
| K801849 | LACTI-QUANT | Nuclear Medical Laboratories, Inc. | 1980-09-16 | 43 | 0 |
| K800388 | NML 5000 AUTO. GAMMA SCINT. COUNTER | Nuclear Medical Laboratories, Inc. | 1980-03-12 | 16 | 0 |
| K792197 | HUMAN CHORIONIC GONADOTROPIN (RIA) | Nuclear Medical Laboratories, Inc. | 1979-12-06 | 35 | 0 |
| K791700 | CORTI-SHURE | Nuclear Medical Laboratories, Inc. | 1979-10-01 | 33 | 0 |
| K790138 | CHORIC-SHURE | Nuclear Medical Laboratories, Inc. | 1979-03-12 | 49 | 0 |
| K781296 | THYRO-SHURE | Nuclear Medical Laboratories, Inc. | 1978-08-31 | 35 | 0 |
| K772177 | TRI-TAB-RIA | Nuclear Medical Laboratories, Inc. | 1977-12-22 | 31 | 0 |
| K770411 | DIGI TROL TM-RX & DIGI TROL TM-TX | Nuclear Medical Laboratories, Inc. | 1977-03-16 | 12 | 0 |
| K761290 | COMPU-PET 300 | Nuclear Medical Laboratories, Inc. | 1977-02-24 | 65 | 0 |
| K760883 | DIGI-TAB-RIA DIGOXIN RADIOMMUNOASSAY | Nuclear Medical Laboratories, Inc. | 1976-11-19 | 29 | 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