FDA 510(k)

MODIFIED LABELING FOR AMUKIN-50%

K-Number: K871583 · 1987-07-09

Decision Date1987-07-09

Product CodeKDJ

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

MODIFIED LABELING FOR AMUKIN-50% is the device name listed in this FDA 510(k) record. The listed applicant is Amuchina Intl., Inc.. It received FDA 510(k) clearance on 1987-07-09 under 510(k) number K871583. The device is classified under product code KDJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED LABELING FOR AMUKIN-50%?

MODIFIED LABELING FOR AMUKIN-50% is a medical device that received FDA 510(k) clearance on 1987-07-09. The listed applicant is Amuchina Intl., Inc.. The 510(k) number is K871583.

When did MODIFIED LABELING FOR AMUKIN-50% receive FDA 510(k) clearance?

MODIFIED LABELING FOR AMUKIN-50% received FDA 510(k) clearance on 1987-07-09, under 510(k) number K871583.

Who is the listed applicant for MODIFIED LABELING FOR AMUKIN-50%?

The FDA 510(k) record lists Amuchina Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFIED LABELING FOR AMUKIN-50%?

The FDA product code for MODIFIED LABELING FOR AMUKIN-50% is KDJ.

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Other records listing Amuchina Intl., Inc. as applicant

K992016AMUKIN D K952302AMUCHINA K862928AMUKIN-50% FOR CAPD Y-SET K852359AMUCHINA/DIALYZER DISINFECTANT

Related Devices (Code: KDJ)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.