Medical Device Manufacturer · US , Mchenry , IL

Nuclear Diagnostics, Inc. - FDA 510(k) Cleared Devices

22 submissions · 22 cleared · Since 1977

22

Total

22

Cleared

0

Denied

FDA 510(k) Regulatory Record - Nuclear Diagnostics, Inc. Chemistry ✕

14 devices

1-12 of 14

Cleared Feb 25, 1994

ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAY

Chemistry · 569d

Cleared Dec 02, 1993

NUCLITRYP(TM)(I125)-HUMAN PANCREA CATH TRY RAD KIT

Chemistry · 203d

Cleared Jun 17, 1987

TIPSEP-CORTISOL RIA DIAGNOSTIC KIT

Chemistry · 9d

Cleared Sep 26, 1986

ENZLIPASE, ENZYMATIC LIPASE KIT

Chemistry · 100d

Cleared Jun 13, 1986

TIPSEP-TBG ASSAY

Chemistry · 38d

Cleared Dec 29, 1983

SERUM THYROTROPIN ASSAY KIT, TIPSEP-

Chemistry · 69d

Cleared Apr 18, 1983

NUCLIPASE (I125) PANCREATIC LIPASE

Chemistry · 117d

Cleared Jun 18, 1981

Chemistry · 16d

Cleared Apr 14, 1981

TRI-LEVEL NDI CONTROL

Chemistry · 11d

Cleared Jan 28, 1981

NUCLI-PAP TM-(I125)-PAP RADIOIMMUNOAS-

Chemistry · 72d

Cleared Jan 16, 1980

TIPSEP-T4(RIA) T4 RADIOIMMUNOASSAY

Chemistry · 29d

Cleared Oct 17, 1978

RIA DIAG. TEST KIT FOR INDEXING THYROX.

Chemistry · 36d