Medical Device Manufacturer · US , Mchenry , IL

Ventrex Laboratories, Inc. - FDA 510(k) Cleared Devices

82 submissions · 82 cleared · Since 1979

Recent clearances: SPECIFIC IGE EIA-TURBO ASSAY, VENTREX ALLERGEN DISC, VENTREX COATED TUBE INTACT PTH

82

Total

82

Cleared

0

Denied

FDA 510(k) Regulatory Record - Ventrex Laboratories, Inc. Chemistry ✕

36 devices

1-12 of 36

Cleared Oct 25, 1991

VENTREX COATED TUBE INTACT PTH

Chemistry · 85d

Cleared Jan 17, 1991

Chemistry · 57d

Cleared Jan 18, 1990

COATED TUBE HIGH SENSITIVITY TSH 100 UIU/ML STAN.

Chemistry · 120d

Cleared Jan 18, 1990

COATED TUBE HIGH SENSITIVITY TSH 200 UIU/ML STAN.

Chemistry · 120d

Cleared Apr 10, 1989

VENTREX COATED TUBE T3 UPTAKE

Chemistry · 40d

Cleared Mar 28, 1989

VENTREX COATED TUBE HCG

Chemistry · 53d

Cleared Feb 10, 1989

VENTREX COATED TUBE HIGH SENSITIVITY TSH

Chemistry · 59d

Cleared Sep 13, 1988

VENTREX COATED TUBE TSH

Chemistry · 35d

Cleared Apr 05, 1988

MODIFIED VENTRESCREEN BETA HCG ENZYME IMMUNOASSAY

Chemistry · 46d

Cleared Nov 23, 1987

VENTRESCREEN, HCG URINE

Chemistry · 34d

Cleared Jul 09, 1984

VENTREZYME PHENYTOIN KIT IMMUNOASSAY

Chemistry · 40d

Cleared May 09, 1984

VENTREZYME T4U IMMUNOASSAY T4U

Chemistry · 58d