Medical Device Manufacturer · US , Mchenry , IL

Vitek Systems, Inc. - FDA 510(k) Cleared Devices

39 submissions · 39 cleared · Since 1978

Recent clearances: VIDAS CMV IGG ASSAY, VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM, VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM

39

Total

39

Cleared

0

Denied

FDA 510(k) Regulatory Record - Vitek Systems, Inc. Toxicology ✕

6 devices

1-6 of 6

Cleared Jan 17, 1979

LIDOCAINE CALIBRATOR KIT

Toxicology · 260d

Cleared Dec 07, 1978

SERUM, CONTROL, DRUGS, ANTIARRYTHMIC

Toxicology · 178d

Cleared Dec 07, 1978

THEOPHYLLINE CONTROL SERUM

Toxicology · 178d

Cleared Nov 22, 1978

PROCAINAMIDE CALIBRATOR KIT

Toxicology · 204d

Cleared Jun 22, 1978

ANTICONVULSANTS III CALIBRATOR KIT

Toxicology · 51d

Cleared Jun 22, 1978

ANTICONVULSANTS II CALIBRATOR KIT

Toxicology · 51d