FDA 510(k)

ULTRAZYME PLUS CK-I

K-Number: K821883 · 1982-07-14

Decision Date1982-07-14

Product CodeCGS

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

ULTRAZYME PLUS CK-I is the device name listed in this FDA 510(k) record. The listed applicant is Harleco Diagnostics. It received FDA 510(k) clearance on 1982-07-14 under 510(k) number K821883. The device is classified under product code CGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRAZYME PLUS CK-I?

ULTRAZYME PLUS CK-I is a medical device that received FDA 510(k) clearance on 1982-07-14. The listed applicant is Harleco Diagnostics. The 510(k) number is K821883.

When did ULTRAZYME PLUS CK-I receive FDA 510(k) clearance?

ULTRAZYME PLUS CK-I received FDA 510(k) clearance on 1982-07-14, under 510(k) number K821883.

Who is the listed applicant for ULTRAZYME PLUS CK-I?

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 ULTRAZYME PLUS CK-I?

The FDA product code for ULTRAZYME PLUS CK-I is CGS.

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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.