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FDA 510(k)

CPK ULTRAZYME PLUS

K-Number: K770694 · 1977-07-01

ApplicantHarleco Diagnostics
Decision Date1977-07-01
Product CodeCGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CPK ULTRAZYME PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Harleco Diagnostics. It received FDA 510(k) clearance on 1977-07-01 under 510(k) number K770694. 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 CPK ULTRAZYME PLUS?

CPK ULTRAZYME PLUS is a medical device that received FDA 510(k) clearance on 1977-07-01. The listed applicant is Harleco Diagnostics. The 510(k) number is K770694.

When did CPK ULTRAZYME PLUS receive FDA 510(k) clearance?

CPK ULTRAZYME PLUS received FDA 510(k) clearance on 1977-07-01, under 510(k) number K770694.

Who is the listed applicant for CPK ULTRAZYME PLUS?

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 CPK ULTRAZYME PLUS?

The FDA product code for CPK ULTRAZYME PLUS is CGS.

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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.

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Related Devices (Code: CGS)

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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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