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FDA 510(k)

ULTRACHEM E-GLU

K-Number: K821868 · 1982-07-08

ApplicantHarleco Diagnostics
Decision Date1982-07-08
Product CodeCFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ULTRACHEM E-GLU is the device name listed in this FDA 510(k) record. The listed applicant is Harleco Diagnostics. It received FDA 510(k) clearance on 1982-07-08 under 510(k) number K821868. 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 ULTRACHEM E-GLU?

ULTRACHEM E-GLU is a medical device that received FDA 510(k) clearance on 1982-07-08. The listed applicant is Harleco Diagnostics. The 510(k) number is K821868.

When did ULTRACHEM E-GLU receive FDA 510(k) clearance?

ULTRACHEM E-GLU received FDA 510(k) clearance on 1982-07-08, under 510(k) number K821868.

Who is the listed applicant for ULTRACHEM E-GLU?

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

What is the FDA product code for ULTRACHEM E-GLU?

The FDA product code for ULTRACHEM E-GLU is CFR.

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Other records listing Harleco Diagnostics 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.

K823147URIC ACID STANDARD, 8MG/DL #65078K822852TRIGLYCERIDE CALIBRATORK822323ULTRACHEM BUN-UV, 65080 & 65081K821880ULTRA CHEM ALBK821877ULTRAZYME PLUS HBDK821879ULTRACHEM T.P.

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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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