Medical Device Manufacturer · US , Washington , DC

Amuchina Intl., Inc. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 1986

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Amuchina Intl., Inc. Gastroenterology & Urology ✕

4 devices

1-4 of 4

Cleared Jan 10, 2000

Gastroenterology & Urology · 209d

Cleared Jul 09, 1987

MODIFIED LABELING FOR AMUKIN-50%

Gastroenterology & Urology · 77d

Cleared Mar 09, 1987

AMUKIN-50% FOR CAPD Y-SET

Gastroenterology & Urology · 220d

Cleared May 13, 1986

AMUCHINA/DIALYZER DISINFECTANT

Gastroenterology & Urology · 343d