Medical Device Manufacturer · US , Salt Lake City , UT

Great Basin Scientific, Inc. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2016

Recent clearances: Great Basin Stool Bacterial Pathogens Panel, Great Basin Bordetella Direct Test, Great Basin Staph ID/R Blood Culture Panel

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Great Basin Scientific, Inc. Microbiology ✕

4 devices

1-4 of 4

Cleared Jul 12, 2017

Great Basin Stool Bacterial Pathogens Panel

Microbiology · 205d

Cleared Mar 31, 2017

Great Basin Bordetella Direct Test

Microbiology · 60d

Cleared Mar 25, 2016

Great Basin Staph ID/R Blood Culture Panel

Microbiology · 207d

Cleared Mar 22, 2016

Great Basin Shiga Toxin Direct Test

Microbiology · 167d