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Ventrex Laboratories, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
82
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K914554SPECIFIC IGE EIA-TURBO ASSAYMarch 13, 1992
K913833VENTREX ALLERGEN DISCFebruary 21, 1992
K913434VENTREX COATED TUBE INTACT PTHOctober 25, 1991
K905612VENTREX COATED TUBE IGE RADIOIMMUNOASSAYFebruary 21, 1991
K905636VENTREX COATED TUBE IGE ENZYME IMMUNOASSAYFebruary 7, 1991
K905247SHBG IRMA KITJanuary 17, 1991
K904330TURBO-RAST SPECIFIC IGE ASSAYDecember 7, 1990
K903000TURBO-RAST SPECIFIC IGE ASSAYJuly 31, 1990
K897083VENTRESIGN STREP A TESTJanuary 22, 1990
K895649COATED TUBE HIGH SENSITIVITY TSH 200 UIU/ML STAN.January 18, 1990
K895648COATED TUBE HIGH SENSITIVITY TSH 100 UIU/ML STAN.January 18, 1990
K896852VENTREX COATED TUBE IGE ENZYME IMMUNOASSAYDecember 18, 1989
K896694VENTREZYME VAST SPECIFIC IGE ASSAYDecember 8, 1989
K891068VENTREX COATED TUBE T3 UPTAKEApril 10, 1989
K890549VENTREX COATED TUBE HCGMarch 28, 1989
K885157VENTREX COATED TUBE HIGH SENSITIVITY TSHFebruary 10, 1989
K883342VENTREX COATED TUBE TSHSeptember 13, 1988
K880678MODIFIED VENTRESCREEN BETA HCG ENZYME IMMUNOASSAYApril 5, 1988
K880547VENTREZYME VAST IMMUNO-PEROXIDASE ASSAYMarch 25, 1988
K874258VENTRESCREEN, HCG URINENovember 23, 1987