Medical Device Manufacturer · US , San Diego , CA

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

11 submissions · 11 cleared · Since 2011

Recent clearances: Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen Fentanyl/Tramadol Dip Card Test, Chemtrue® Multi-Panel Drug Screen Cup Test, Chemtrue® Multi-Panel Drug Screen Dip Card Test

11

Total

11

Cleared

0

Denied

FDA 510(k) Regulatory Record - Chemtron Biotech, Inc. Chemistry ✕

2 devices

1-2 of 2

Cleared Jul 26, 2013

CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TEST

Chemistry · 29d

Cleared May 30, 2013

CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST,...

Chemistry · 168d