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FDA 510(k)

ULTRA CHEM E-GLU #64976 & 65040

K-Number: K812595 · 1981-09-29

ApplicantHarleco
Decision Date1981-09-29
Product CodeCFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ULTRA CHEM E-GLU #64976 & 65040 is the device name listed in this FDA 510(k) record. The listed applicant is Harleco. It received FDA 510(k) clearance on 1981-09-29 under 510(k) number K812595. The device is classified under product code CFR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRA CHEM E-GLU #64976 & 65040?

ULTRA CHEM E-GLU #64976 & 65040 is a medical device that received FDA 510(k) clearance on 1981-09-29. The listed applicant is Harleco. The 510(k) number is K812595.

When did ULTRA CHEM E-GLU #64976 & 65040 receive FDA 510(k) clearance?

ULTRA CHEM E-GLU #64976 & 65040 received FDA 510(k) clearance on 1981-09-29, under 510(k) number K812595.

Who is the listed applicant for ULTRA CHEM E-GLU #64976 & 65040?

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

What is the FDA product code for ULTRA CHEM E-GLU #64976 & 65040?

The FDA product code for ULTRA CHEM E-GLU #64976 & 65040 is CFR.

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Other records listing Harleco as applicant

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

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Related Devices (Code: CFR)

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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.

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