FDA 510(k)

ULTRAZYME PLUS GOT

K-Number: K770883 · 1977-07-14

Decision Date1977-07-14

Product Code

DecisionSubstantially Equivalent

Device Summary

ULTRAZYME PLUS GOT is the device name listed in this FDA 510(k) record. The listed applicant is Harleco. It received FDA 510(k) clearance on 1977-07-14 under 510(k) number K770883. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRAZYME PLUS GOT?

ULTRAZYME PLUS GOT is a medical device that received FDA 510(k) clearance on 1977-07-14. The listed applicant is Harleco. The 510(k) number is K770883.

When did ULTRAZYME PLUS GOT receive FDA 510(k) clearance?

ULTRAZYME PLUS GOT received FDA 510(k) clearance on 1977-07-14, under 510(k) number K770883.

Who is the listed applicant for ULTRAZYME PLUS GOT?

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

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Other records listing Harleco as applicant

K820233ULTRAZYME PLUS GAMMA GT(65055-65056)K813427ULTRACHEM GLUC-DH K813044ULTRACHEM ALB, ITEM #64970 K813042ULTRACHEM GLUC-DH SET, ITEM #65048 K813038ULTRACHEM TP, ITEM #64974 K813041ULTRAZYME-GT, ITEM #64959 & 65032

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Official Source

View on FDA Database →

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