Medical Device Manufacturer · US , St. Charles , MO

Dimension Diagnostics - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 1985

8

Total

8

Cleared

0

Denied

FDA 510(k) Regulatory Record - Dimension Diagnostics Chemistry ✕

7 devices

1-7 of 7

Cleared Mar 10, 1987

Chemistry · 201d

Cleared Jun 25, 1986

ALT-30, 60 AND 100

Chemistry · 75d

Cleared Jan 07, 1986

CRITIC - SF, ASSAYED

Chemistry · 27d

Cleared Jul 22, 1985

Chemistry · 54d

Cleared Mar 01, 1985

IMA-TROL IMMUNOASSAY CONTROL

Chemistry · 78d

Cleared Jan 08, 1985

Chemistry · 36d

Cleared Jan 08, 1985

Chemistry · 32d