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Kent Laboratories, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
40
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K951966HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KITJune 1, 1995
K951968HUMAN C1Q RADIAL IMMUNODIFFUSION KITMay 30, 1995
K951967HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KITMay 30, 1995
K950102HUMAN C-5 RADIAL IMMUNODIFFUSION KITApril 10, 1995
K85068372 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2November 27, 1985
K85068272 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPLNovember 25, 1985
K850690ANTISERUM TO HUMAN APOLIPOPROTEIN BNovember 1, 1985
K850691ANTISERUM TO HUMAN APOLIPOPROTEIN A-INovember 1, 1985
K850686ANTISERUM TO HUMAN PREALBUMINNovember 1, 1985
K831961IMMUNODIFFUSION TEST HUMAN ANTITHROMBINAugust 11, 1983
K831960TEST FOR HUMAN ALPHA ONE ACID GLYCO-July 19, 1983
K831958RADIAL IMMUNO-TEST FOR HUMAN C-REACTIJuly 19, 1983
K831959RADIAL IMMUNO-TEST FOR HUMAN FACTOR BJuly 19, 1983
K831957DETERM. SIZE 72 RADIAL HUMAN HAPTOGLOBJuly 18, 1983
K831956DETERM. SIZE 72 RADIAL-HUMAN IGDJuly 18, 1983
K823765ANTI SERA TO HUMAN OROSCOMUCOIDDecember 30, 1982
K822472ANTISERA TO HUMAN FERRITINSeptember 30, 1982
K81161372 DETERMIN. SIZE RADIAL IMMUNOD. TESTAugust 12, 1981
K790706ANTISERUM TO RABBIT IGG H & L CHAINSeptember 12, 1979
K790711ANTISERA TO HUMAN FRAGMENTSeptember 4, 1979