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FDA 510(k)

GEMSAEC APPLI. FOR ULTRAZYME PLUS CK-1

K-Number: K772034 · 1977-11-17

ApplicantHarleco
Decision Date1977-11-17
Product Code
DecisionSubstantially Equivalent

Device Summary

GEMSAEC APPLI. FOR ULTRAZYME PLUS CK-1 is the device name listed in this FDA 510(k) record. The listed applicant is Harleco. It received FDA 510(k) clearance on 1977-11-17 under 510(k) number K772034. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GEMSAEC APPLI. FOR ULTRAZYME PLUS CK-1?

GEMSAEC APPLI. FOR ULTRAZYME PLUS CK-1 is a medical device that received FDA 510(k) clearance on 1977-11-17. The listed applicant is Harleco. The 510(k) number is K772034.

When did GEMSAEC APPLI. FOR ULTRAZYME PLUS CK-1 receive FDA 510(k) clearance?

GEMSAEC APPLI. FOR ULTRAZYME PLUS CK-1 received FDA 510(k) clearance on 1977-11-17, under 510(k) number K772034.

Who is the listed applicant for GEMSAEC APPLI. FOR ULTRAZYME PLUS CK-1?

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K820233ULTRAZYME PLUS GAMMA GT(65055-65056)K813427ULTRACHEM GLUC-DHK813044ULTRACHEM ALB, ITEM #64970K813042ULTRACHEM GLUC-DH SET, ITEM #65048K813038ULTRACHEM TP, ITEM #64974K813041ULTRAZYME-GT, ITEM #64959 & 65032

View all 116 devices →

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.

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