Nuclear Diagnostics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
24
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K021656HERMES HDAQ ACQUISITION STATION AND HERMES WORKSTATION, VER. 3.4June 13, 2002
K002782HERMES HD AQ ACQUISITION STATION AND HERMES WORKSTATIONDecember 5, 2000
K923917ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAYFebruary 25, 1994
K932406NUCLITRYP(TM)(I125)-HUMAN PANCREA CATH TRY RAD KITDecember 2, 1993
K872177TIPSEP-CORTISOL RIA DIAGNOSTIC KITJune 17, 1987
K862312ENZLIPASE, ENZYMATIC LIPASE KITSeptember 26, 1986
K860472NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESSJuly 3, 1986
K861735TIPSEP-TBG ASSAYJune 13, 1986
K852291TIPSEP DIGOXIN RIAJune 25, 1985
K833713SERUM THYROTROPIN ASSAY KIT, TIPSEP-December 29, 1983
K823860NUCLIPASE (I125) PANCREATIC LIPASEApril 18, 1983
K811558TSH-P.E.G.June 18, 1981
K810906TRI-LEVEL NDI CONTROLApril 14, 1981
K802886NUCLI-PAP TM-(I125)-PAP RADIOIMMUNOAS-January 28, 1981
K792599TIPSEP-T4(RIA) T4 RADIOIMMUNOASSAYJanuary 16, 1980
K792484TIPSEP-T3U TRIIODOTHYRONINE UPTAKEDecember 27, 1979
K790133SPINSEP-FE59March 2, 1979
K781560RIA DIAG. TEST KIT FOR INDEXING THYROX.October 17, 1978
K780644RADIOASSAY FOR TOTAL SERUM THYROXINEApril 28, 1978
K780486STIKSEP-T3 KITApril 28, 1978