Medical Device Manufacturer · US , Martinez , GA

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

5 submissions · 5 cleared · Since 1992

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Shared Systems, Inc. Microbiology ✕

3 devices

1-3 of 3

Cleared Jan 02, 1998

CHROMALEX E. COLI 0157 LATEX TEST SYSTEM, PROD. NO. 800

Microbiology · 112d

Cleared Oct 17, 1995

MYCOPLASMA PNEUMONIAE ANTIBODY LATEX AGGLUTINATION TEST SYSTEM

Microbiology · 281d

Cleared Aug 20, 1992

MYCOPLASMA PNEUMONIAE ANTIBODY EIA TEST SYSTEM

Microbiology · 217d