Nuclear Diagnostics, Inc.
Beltsville, MD, US
Nuclear Diagnostics, Inc. appears in FDA device records in Beltsville, MD. FDA records list 24 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 24
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 24 510(k) clearances for Nuclear Diagnostics, Inc. between 1977 and 2002. The busiest year on record is 1978, with 5. The most recent is 2002, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 2 |
| 1978 | 5 |
| 1979 | 2 |
| 1980 | 1 |
| 1981 | 3 |
| 1983 | 2 |
| 1985 | 1 |
| 1986 | 3 |
| 1987 | 1 |
| 1993 | 1 |
| 1994 | 1 |
| 2000 | 1 |
| 2002 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K021656 | HERMES HDAQ ACQUISITION STATION AND HERMES WORKSTATION, VER. 3.4 | KPS | Substantially Equivalent | |
| K002782 | HERMES HD AQ ACQUISITION STATION AND HERMES WORKSTATION | LLZ | Substantially Equivalent | |
| K923917 | ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAY | CHI | Substantially Equivalent | |
| K932406 | NUCLITRYP(TM)(I125)-HUMAN PANCREA CATH TRY RAD KIT | JNO | Substantially Equivalent | |
| K872177 | TIPSEP-CORTISOL RIA DIAGNOSTIC KIT | CGR | Substantially Equivalent | |
| K862312 | ENZLIPASE, ENZYMATIC LIPASE KIT | CHI | Substantially Equivalent | |
| K860472 | NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESS | IWE | Substantially Equivalent | |
| K861735 | TIPSEP-TBG ASSAY | CEE | Substantially Equivalent | |
| K852291 | TIPSEP DIGOXIN RIA | DNL | Substantially Equivalent | |
| K833713 | SERUM THYROTROPIN ASSAY KIT, TIPSEP- | JLW | Substantially Equivalent | |
| K823860 | NUCLIPASE (I125) PANCREATIC LIPASE | CET | Substantially Equivalent | |
| K811558 | TSH-P.E.G. | JLW | Substantially Equivalent | |
| K810906 | TRI-LEVEL NDI CONTROL | JJY | Substantially Equivalent | |
| K802886 | NUCLI-PAP TM-(I125)-PAP RADIOIMMUNOAS- | JFH | Substantially Equivalent | |
| K792599 | TIPSEP-T4(RIA) T4 RADIOIMMUNOASSAY | CDX | Substantially Equivalent | |
| K792484 | TIPSEP-T3U TRIIODOTHYRONINE UPTAKE | KHQ | Substantially Equivalent | |
| K790133 | SPINSEP-FE59 | JQG | Substantially Equivalent | |
| K781560 | RIA DIAG. TEST KIT FOR INDEXING THYROX. | CEC | Substantially Equivalent | |
| K780644 | RADIOASSAY FOR TOTAL SERUM THYROXINE | CDX | Substantially Equivalent | |
| K780486 | STIKSEP-T3 KIT | CEE | Substantially Equivalent | |
| K780423 | STIKSEP-T4 RIA KIT | CDX | Substantially Equivalent | |
| K780292 | TRIA-PEG RIA DIAG. KIT | CDP | Substantially Equivalent | |
| K771854 | SPINSEP-T3 | KHQ | Substantially Equivalent | |
| K771341 | SPINSEP-TBG | CEE | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JFHAcid Phosphatase (Prostatic), Tartrate Inhibited
- CHILipase-Esterase, Enzymatic, Photometric, Lipase
- IWEMonitor, Patient Position, Light-Beam
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- JNON-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin
- CETOlive Oil Emulsion (Turbidimetric), Lipase
- KHQRadioassay, Triiodothyronine Uptake
- CGRRadioimmunoassay, Cortisol
- DNLRadioimmunoassay, Digoxin (125-I), Rabbit Antibody, Second Antibody Sep.
- CECRadioimmunoassay, Free Thyroxine
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- CEERadioimmunoassay, Thyroxine-Binding Globulin
- CDXRadioimmunoassay, Total Thyroxine
- CDPRadioimmunoassay, Total Triiodothyronine
- JQGRadiometric, Fe59, Iron Binding Capacity
- LLZSystem, Image Processing, Radiological
- KPSSystem, Tomography, Computed, Emission
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain