AMUKIN D— 510(k) K992016

Substantially Equivalent

Amuchina Intl., Inc.

FDA 510(k) clearance K992016 for AMUKIN D, Substantially Equivalent on 2000-01-10. Applicant: Amuchina Intl., Inc.. Device class: 2.

Clearance details

Applicant: Amuchina Intl., Inc.
Product code: Code LIF
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1999-06-15
Decision date: 2000-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gaithersburg, MD, US

Download summary PDF View on FDA.gov ↗

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More clearances from Amuchina Intl., Inc.

K952302 — AMUCHINA1995-07-26
K871583 — MODIFIED LABELING FOR AMUKIN-50%1987-07-09
K862928 — AMUKIN-50% FOR CAPD Y-SET1987-03-09
K852359 — AMUCHINA/DIALYZER DISINFECTANT1986-05-13

Data sourced from openFDA. This site is unofficial and independent of the FDA.