Medical Device Manufacturer · US , MD

Sigma - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 1983

Recent clearances: SMART ADJUSTER (SA201)

Official Website

6

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - Sigma Hematology ✕

2 devices

1-2 of 2

Cleared May 15, 1985

MCDB-110 MED. M6520 W/L-GLUTAMINE-25M M HERPES &

Hematology · 20d

Cleared May 15, 1985

MCDB-105 MED. M6395, W/L-GLUTAMINE, 25M M HERPES &

Hematology · 20d