Company ยท US
Nuclear Diagnostics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 2002. Name variants (Inc, Corp, punctuation) are merged.
24510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CDX | Radioimmunoassay, Total Thyroxine | 3 |
| CEE | Radioimmunoassay, Thyroxine-Binding Globulin | 3 |
| CHI | Lipase-Esterase, Enzymatic, Photometric, Lipase | 2 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 2 |
| KHQ | Radioassay, Triiodothyronine Uptake | 2 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 |
| CEC | Radioimmunoassay, Free Thyroxine | 1 |
| CET | Olive Oil Emulsion (Turbidimetric), Lipase | 1 |
| CGR | Radioimmunoassay, Cortisol | 1 |
| DNL | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Second Antibody Sep. | 1 |
| IWE | Monitor, Patient Position, Light-Beam | 1 |
| JFH | Acid Phosphatase (Prostatic), Tartrate Inhibited | 1 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 |
| JNO | N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin | 1 |
| JQG | Radiometric, Fe59, Iron Binding Capacity | 1 |
| KPS | System, Tomography, Computed, Emission | 1 |
| LLZ | System, Image Processing, Radiological | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 13, 2002 | K021656 | HERMES HDAQ ACQUISITION STATION AND HERMES WORKSTATION, VER. 3.4 Nuclear Diagnostics, SE | KPS |
| Dec 5, 2000 | K002782 | HERMES HD AQ ACQUISITION STATION AND HERMES WORKSTATION Nuclear Diagnostics AB | LLZ |
| Feb 25, 1994 | K923917 | ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAY Nuclear Diagnostics, Inc. | CHI |
| Dec 2, 1993 | K932406 | NUCLITRYP(TM)(I125)-HUMAN PANCREA CATH TRY RAD KIT Nuclear Diagnostics, Inc. | JNO |
| Jun 17, 1987 | K872177 | TIPSEP-CORTISOL RIA DIAGNOSTIC KIT Nuclear Diagnostics, Inc. | CGR |
| Sep 26, 1986 | K862312 | ENZLIPASE, ENZYMATIC LIPASE KIT Nuclear Diagnostics, Inc. | CHI |
| Jul 3, 1986 | K860472 | NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESS Nuclear Diagnostics, Inc. | IWE |
| Jun 13, 1986 | K861735 | TIPSEP-TBG ASSAY Nuclear Diagnostics, Inc. | CEE |
| Jun 25, 1985 | K852291 | TIPSEP DIGOXIN RIA Nuclear Diagnostics, Inc. | DNL |
| Dec 29, 1983 | K833713 | SERUM THYROTROPIN ASSAY KIT, TIPSEP- Nuclear Diagnostics, Inc. | JLW |
| Apr 18, 1983 | K823860 | NUCLIPASE (I125) PANCREATIC LIPASE Nuclear Diagnostics, Inc. | CET |
| Jun 18, 1981 | K811558 | TSH-P.E.G. Nuclear Diagnostics, Inc. | JLW |
| Apr 14, 1981 | K810906 | TRI-LEVEL NDI CONTROL Nuclear Diagnostics, Inc. | JJY |
| Jan 28, 1981 | K802886 | NUCLI-PAP TM-(I125)-PAP RADIOIMMUNOAS- Nuclear Diagnostics, Inc. | JFH |
| Jan 16, 1980 | K792599 | TIPSEP-T4(RIA) T4 RADIOIMMUNOASSAY Nuclear Diagnostics, Inc. | CDX |
| Dec 27, 1979 | K792484 | TIPSEP-T3U TRIIODOTHYRONINE UPTAKE Nuclear Diagnostics, Inc. | KHQ |
| Mar 2, 1979 | K790133 | SPINSEP-FE59 Nuclear Diagnostics, Inc. | JQG |
| Oct 17, 1978 | K781560 | RIA DIAG. TEST KIT FOR INDEXING THYROX. Nuclear Diagnostics, Inc. | CEC |
| Apr 28, 1978 | K780644 | RADIOASSAY FOR TOTAL SERUM THYROXINE Nuclear Diagnostics, Inc. | CDX |
| Apr 28, 1978 | K780486 | STIKSEP-T3 KIT Nuclear Diagnostics, Inc. | CEE |
| Mar 30, 1978 | K780423 | STIKSEP-T4 RIA KIT Nuclear Diagnostics, Inc. | CDX |
| Mar 2, 1978 | K780292 | TRIA-PEG RIA DIAG. KIT Nuclear Diagnostics, Inc. | CDP |
| Dec 22, 1977 | K771854 | SPINSEP-T3 Nuclear Diagnostics, Inc. | KHQ |
| Aug 10, 1977 | K771341 | SPINSEP-TBG Nuclear Diagnostics, Inc. | CEE |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||