Medical Device Manufacturer · US , San Diego , CA

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

12 submissions · 12 cleared · Since 1995

12

Total

12

Cleared

0

Denied

FDA 510(k) Regulatory Record - Wyntek Diagnostics, Inc. Chemistry ✕

9 devices

1-9 of 9

Cleared Mar 09, 1999

OSOM CARD PREGNANCY TEST, MODEL 103

Chemistry · 14d

Cleared Mar 09, 1999

OSOM CARD II HCG-URINE TEST, MODEL 102

Chemistry · 14d

Cleared Dec 24, 1997

OSOM HCG-URINE TEST MODEL 101

Chemistry · 71d

Cleared Nov 04, 1997

OSOM CARD HCG-URINE TEST

Chemistry · 55d

Cleared Feb 04, 1997

PERFECTA PREGNANCY TEST

Chemistry · 42d

Cleared Feb 04, 1997

OSOM CLASSIC HCG-URINE TEST (115)

Chemistry · 36d

Cleared Dec 06, 1995

OSOM HCG COMBO TEST

Chemistry · 23d

Cleared Oct 23, 1995

OSOM PREGNANCY TEST

Chemistry · 48d

Cleared Aug 29, 1995

WYNTEK OSOM HCG-URINE TEST

Chemistry · 41d