Medical Device Manufacturer · US , Shelton , CT

In Vitro Diagnostics, Inc. - FDA 510(k) Cleared Devices

15 submissions · 15 cleared · Since 1985

15

Total

15

Cleared

0

Denied

FDA 510(k) Regulatory Record - In Vitro Diagnostics, Inc. Chemistry ✕

12 devices

1-12 of 12

Cleared Feb 23, 1990

THYROID STIMULATING HORMONE-EIA-XT

Chemistry · 79d

Cleared Feb 13, 1990

LUTEINIZING HORMONE-EIA-XT

Chemistry · 69d

Cleared Jan 30, 1990

VITRO T4-EIA-XT

Chemistry · 55d

Cleared Jan 18, 1990

T UPTAKE ENZYME IMMUNOASSAY CRIMPED TUBE KIT

Chemistry · 37d

Cleared Jan 11, 1990

FOLLICLE STIMULATING HORMONE-EIA-XT

Chemistry · 36d

Cleared May 28, 1987

FLAME PHOTOMETER STANDARD #60081 120 NA/2K

Chemistry · 65d

Cleared May 28, 1987

FLAME PHOTOMETER STANDARD #60082 140 NA/5K

Chemistry · 65d

Cleared May 28, 1987

FLAME PHOTOMETER STANDARD #60083 160 NA/8K

Chemistry · 65d

Cleared May 28, 1987

LITHIUM INTERNAL STANDARD 1 MEQ/L #60085

Chemistry · 65d

Cleared May 28, 1987

CESIUM DILUENT 1.5 MMOL CS/L #60087

Chemistry · 65d

Cleared May 28, 1987

LITHIUM INTERNAL STANDARD 3000 MEQ/L #60084

Chemistry · 65d

Cleared May 28, 1987

LITHIUM INTERNAL STANDARD 1500 MEQ/L #60086

Chemistry · 65d