Medical Device Manufacturer · US , Mchenry , IL

Nuclear Diagnostics, Inc.

22 submissions · 22 cleared · Since 1977
22
Total
22
Cleared
0
Denied

Nuclear Diagnostics, Inc. — FDA 510(k) Submissions

Nuclear Diagnostics, Inc. has submitted 22 FDA 510(k) premarket notifications since 1977, of which 22 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Radioimmunoassay, Thyroxine-binding Globulin, Radioimmunoassay, Total Thyroxine, Radioimmunoassay, Thyroid-stimulating Hormone, Radioassay, Triiodothyronine Uptake, Lipase-esterase, Enzymatic, Photometric, Lipase . Use the specialty filter in the sidebar to narrow results.

22 devices
1–22 of 22
ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAY
K923917 · CHI Lipase-esterase,... · Chemistry
Feb 1994 569d
NUCLITRYP(TM)(I125)-HUMAN PANCREA CATH TRY RAD KIT
K932406 · JNO N-benzoyl-l-arginine... · Chemistry
Dec 1993 203d
TIPSEP-CORTISOL RIA DIAGNOSTIC KIT
K872177 · CGR Radioimmunoassay, Cortisol · Chemistry
Jun 1987 9d
ENZLIPASE, ENZYMATIC LIPASE KIT
K862312 · CHI Lipase-esterase,... · Chemistry
Sep 1986 100d
NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESS
K860472 · IWE Monitor, Patient... · Radiology
Jul 1986 147d
TIPSEP-TBG ASSAY
K861735 · CEE Radioimmunoassay,... · Chemistry
Jun 1986 38d
TIPSEP DIGOXIN RIA
K852291 · DNL Radioimmunoassay, Digoxin... · Toxicology
Jun 1985 27d
SERUM THYROTROPIN ASSAY KIT, TIPSEP-
K833713 · JLW Radioimmunoassay,... · Chemistry
Dec 1983 69d
NUCLIPASE (I125) PANCREATIC LIPASE
K823860 · CET Olive Oil Emulsion... · Chemistry
Apr 1983 117d
TSH-P.E.G.
K811558 · JLW Radioimmunoassay,... · Chemistry
Jun 1981 16d
TRI-LEVEL NDI CONTROL
K810906 · JJY Multi-analyte Controls,... · Chemistry
Apr 1981 11d
NUCLI-PAP TM-(I125)-PAP RADIOIMMUNOAS-
K802886 · JFH Acid Phosphatase... · Chemistry
Jan 1981 72d
TIPSEP-T4(RIA) T4 RADIOIMMUNOASSAY
K792599 · CDX Radioimmunoassay, Total... · Chemistry
Jan 1980 29d
TIPSEP-T3U TRIIODOTHYRONINE UPTAKE
K792484 · KHQ Radioassay,... · Toxicology
Dec 1979 24d
SPINSEP-FE59
K790133 · JQG Radiometric, Fe59, Iron... · Immunology
Mar 1979 38d
RIA DIAG. TEST KIT FOR INDEXING THYROX.
K781560 · CEC Radioimmunoassay, Free... · Chemistry
Oct 1978 36d
STIKSEP-T3 KIT
K780486 · CEE Radioimmunoassay,... · Chemistry
Apr 1978 32d
RADIOASSAY FOR TOTAL SERUM THYROXINE
K780644 · CDX Radioimmunoassay, Total... · Toxicology
Apr 1978 11d
STIKSEP-T4 RIA KIT
K780423 · CDX Radioimmunoassay, Total... · Toxicology
Mar 1978 14d
TRIA-PEG RIA DIAG. KIT
K780292 · CDP Radioimmunoassay, Total... · Toxicology
Mar 1978 9d
SPINSEP-T3
K771854 · KHQ Radioassay,... · Immunology
Dec 1977 85d
SPINSEP-TBG
K771341 · CEE Radioimmunoassay,... · Chemistry
Aug 1977 22d
Filters