Nuclear Diagnostics, Inc.: FDA filings under this applicant name
FDA lists 23 510(k) clearances under 2 spellings of the applicant name “Nuclear Diagnostics, Inc.” (first 1977, latest 2002), across 16 product codes in 3 review panels. Median 510(k) review time under this name: 32 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CDX | Radioimmunoassay, Total Thyroxine | 3 | 3 |
| CEE | Radioimmunoassay, Thyroxine-Binding Globulin | 3 | 3 |
| CHI | Lipase-Esterase, Enzymatic, Photometric, Lipase | 2 | 2 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 2 | 2 |
| KHQ | Radioassay, Triiodothyronine Uptake | 2 | 2 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 | 1 |
| CEC | Radioimmunoassay, Free Thyroxine | 1 | 1 |
| CET | Olive Oil Emulsion (Turbidimetric), Lipase | 1 | 1 |
| CGR | Radioimmunoassay, Cortisol | 1 | 1 |
| DNL | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Second Antibody Sep. | 1 | 1 |
Plus 6 more product codes.
Review panels
- Clinical Chemistry (20)
- Radiology (2)
- Clinical Toxicology (1)
Most recent Nuclear Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K021656 | HERMES HDAQ ACQUISITION STATION AND HERMES WORKSTATION, VER. 3.4 | KPS | 2002-06-13 | 24 |
| K923917 | ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAY | CHI | 1994-02-25 | 569 |
| K932406 | NUCLITRYP(TM)(I125)-HUMAN PANCREA CATH TRY RAD KIT | JNO | 1993-12-02 | 203 |
| K872177 | TIPSEP-CORTISOL RIA DIAGNOSTIC KIT | CGR | 1987-06-17 | 9 |
| K862312 | ENZLIPASE, ENZYMATIC LIPASE KIT | CHI | 1986-09-26 | 100 |
| K860472 | NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESS | IWE | 1986-07-03 | 147 |
| K861735 | TIPSEP-TBG ASSAY | CEE | 1986-06-13 | 38 |
| K852291 | TIPSEP DIGOXIN RIA | DNL | 1985-06-25 | 27 |
| K833713 | SERUM THYROTROPIN ASSAY KIT, TIPSEP- | JLW | 1983-12-29 | 69 |
| K823860 | NUCLIPASE (I125) PANCREATIC LIPASE | CET | 1983-04-18 | 117 |
13 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Nuclear Diagnostics, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Nuclear Diagnostics, Inc. (22)
- Nuclear Diagnostics (1)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Nuclear Medical Laboratories, Inc. (24 510(k)s)
- Nuclear Data, Inc. (7 510(k)s)
- Nuclear Medical Systems, Inc. (5 510(k)s)
- Nuclear Ent. , Ltd. (3 510(k)s)
- Nuclear Cardiology Systems, Inc. (2 510(k)s)
- Nuclear Data Systems (2 510(k)s)
- Nuclear Assoc., Div. Inovision LP (1 510(k)s)
- Nuclear Associates (1 510(k)s)
- Nuclear Concepts, Inc. (1 510(k)s)
- Nuclear Diagnostics AB (1 510(k)s)
- Nuclear Medicine, Inc. (1 510(k)s)
- Nuclear Pacific, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Nuclear Diagnostics, Inc.?
FDA lists 23 510(k) clearances under 2 spellings of the applicant name “Nuclear Diagnostics, Inc.” (first 1977, latest 2002), across 16 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Nuclear Diagnostics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nuclear Diagnostics, Inc. is 32 days.
Which FDA product codes appear under Nuclear Diagnostics, Inc.?
The most frequent FDA product codes under this applicant name are CDX (Radioimmunoassay, Total Thyroxine, 3); CEE (Radioimmunoassay, Thyroxine-Binding Globulin, 3); CHI (Lipase-Esterase, Enzymatic, Photometric, Lipase, 2).
Next steps
- See all 23 Nuclear Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CDX, Nuclear Diagnostics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.