Medical Device Manufacturer · US , Hatboro , PA

Simplicity Diagnostics, Inc. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 1992

Recent clearances: TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL, TECH DIMPLE C-REACTIVE PROTEIN SERUM CONTROL, TECH SIMPLE RHEUMATOID FACTOR SERUM CONTROL

View 5 510(k) Devices ↓

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Simplicity Diagnostics, Inc. Microbiology ✕

2 devices

1-2 of 2

Cleared Mar 10, 1997

TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE...

Microbiology · 59d

Cleared Sep 18, 1992

TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROL

Microbiology · 105d