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Orgentec

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
10
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K954830ORGENTEC ANTI-SM(SMITH) PIN IMMUNO ASSAYMay 8, 1996
K954831ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAYMay 8, 1996
K954815ORGENTEC ANTI-SS-A(RO) PIN IMMUNO ASSAYApril 18, 1996
K954832ORGENTEC ANTI-SS-B(LA) PIN IMMUNO ASSAYApril 18, 1996
K954814ORGENTEC ANTI-SCL 70 PIN IMMUNO ASSAYApril 18, 1996
K954829ORGENTEC ANTI-JO-1 PIN IMMUNO ASSAYApril 18, 1996
K960274ORGENTEC MICRO-ALBUMIN PIN EIA ASSAYMarch 29, 1996
K955133ORGENTEC ENASCREEN PIN IMMUNO ASSAYMarch 20, 1996
K955134ORGENTEC ENASCREEN ELISA ASSAYMarch 20, 1996
K953671ORGEN TEC ANTI-DSDNA ELISA ASSAYNovember 9, 1995