Medical Device Manufacturer · US , Portland , OR

Athena Medical Corp. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 1996

Recent clearances: AFFIRM ONE-STEP PROFESSIONAL PREGNANCY TEST, AFFIRM ONE-STEP HOME PREGNANCY TEST

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Athena Medical Corp. Chemistry ✕

2 devices

1-2 of 2

Cleared Jan 21, 1997

AFFIRM ONE-STEP PROFESSIONAL PREGNANCY TEST

Chemistry · 68d

Cleared Sep 23, 1996

AFFIRM ONE-STEP HOME PREGNANCY TEST

Chemistry · 61d