FDA 510(k)

ULTRACHEM TRI-ES

K-Number: K821875 · 1982-07-13

Decision Date1982-07-13

Product CodeCDT

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

ULTRACHEM TRI-ES is the device name listed in this FDA 510(k) record. The listed applicant is Harleco Diagnostics. It received FDA 510(k) clearance on 1982-07-13 under 510(k) number K821875. The device is classified under product code CDT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRACHEM TRI-ES?

ULTRACHEM TRI-ES is a medical device that received FDA 510(k) clearance on 1982-07-13. The listed applicant is Harleco Diagnostics. The 510(k) number is K821875.

When did ULTRACHEM TRI-ES receive FDA 510(k) clearance?

ULTRACHEM TRI-ES received FDA 510(k) clearance on 1982-07-13, under 510(k) number K821875.

Who is the listed applicant for ULTRACHEM TRI-ES?

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 TRI-ES?

The FDA product code for ULTRACHEM TRI-ES is CDT.

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Other records listing Harleco Diagnostics as applicant

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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.