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Gull Laboratories, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
57
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K983541HSV 1+2 IGG ELISA TESTFebruary 26, 1999
K971857MUMPS IGG ELISA TESTYNovember 4, 1997
K962343TOXO IGG ELISA TESTMarch 24, 1997
K935730EBNA IGG ELISA TESTSeptember 19, 1995
K940093EBV-EA(D) IGG ELISA TESTSeptember 15, 1995
K941046VZV IGG ELISA TESTAugust 24, 1995
K941198EBV LGG ELISA TESTAugust 23, 1995
K932333PROTECTORAL ULTRASONIC HANDPIECE PROCESSORAugust 15, 1995
K941624RUBELLA IGG ELISA TESTAugust 4, 1995
K922759HSV-2 IGM ELISA TEST--MODIFICATIONOctober 5, 1992
K922758HSV-1 IGM ELISA TEST -- MODIFICATIONOctober 5, 1992
K911233CHAGAS' IGG ELISA TESTMay 4, 1992
K915893RUBELLA IGG ELISA TESTMarch 4, 1992
K915891TOXO IGG ELISA TEST (MODIFIED)March 4, 1992
K915892CMV IGG ELISA TESTFebruary 14, 1992
K913351INFLUENZA MAB TEST/INFLUENZA A TESTDecember 17, 1991
K913214INFLUENZA MAB TEST/INFLUENZA B TESTDecember 13, 1991
K912842RSV-MAB TESTDecember 9, 1991
K912592CMV-EA MAB TESTDecember 4, 1991
K912558GULL ELISAWARESeptember 16, 1991