Medical Device Manufacturer · US , Bozeman , MT

Sgm Biotech, Inc. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 1994

Recent clearances: SMART-READ EZTEST-STEAM SCBI AND TEST PACK, SMART-WELL EZTEST INCUBATOR, EZTEST

View 4 510(k) Devices ↓

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Sgm Biotech, Inc. General Hospital ✕

4 devices

1-4 of 4

Cleared May 14, 2010

SMART-READ EZTEST-STEAM SCBI AND TEST PACK

General Hospital · 155d

Cleared Jan 15, 2010

SMART-WELL EZTEST INCUBATOR

General Hospital · 198d

Cleared Feb 25, 1997

General Hospital · 153d

Cleared Apr 04, 1994

General Hospital · 418d