Medical Device Manufacturer · US , San Diego , CA

Phamatech - FDA 510(k) Cleared Devices

47 submissions · 47 cleared · Since 1996

Recent clearances: QUICKSCREEN, MODELS 9177X AND 9178X, AT HOME DRUG CUP, MODEL 9150X, AT WORK DRUG TEST, MODEL 9177T AWT

47

Total

47

Cleared

0

Denied

FDA 510(k) Regulatory Record - Phamatech Chemistry ✕

10 devices

1-10 of 10

Cleared Sep 10, 2004

QUICKSCREEN, MODELS 9177X AND 9178X

Chemistry · 88d

Cleared Nov 08, 1999

AT HOME QUICKCUP PREGNANCY TEST, MODEL 9015

Chemistry · 48d

Cleared Apr 28, 1999

QUICKCARD HCG COMBO TEST, MODEL #9014

Chemistry · 27d

Cleared Mar 22, 1999

OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVULATION PREDICTOR,...

Chemistry · 55d

Cleared Apr 02, 1998

QUICKCARD PRO HCG TEST, MODEL 9008

Chemistry · 24d

Cleared Mar 11, 1998

QUICKSTREAM ONE STEP PREGNANCY TEST MODEL NUMBER 9012

Chemistry · 28d

Cleared Jan 26, 1998

QUICKSTICK PRO HCG TEST

Chemistry · 46d

Cleared Oct 31, 1997

QUICK CARD HCG ONE STEP PREGNANCY TEST

Chemistry · 42d

Cleared Aug 01, 1997

QUICKSTICK ONE STEP HCG PREGNANCY TEST

Chemistry · 15d

Cleared Jul 23, 1996

QUICKSTICK ONE STEP PREGNANCY TEST(9010)

Chemistry · 43d