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FDA 510(k)

CPK-INT TEST

K-Number: K771154 · 1977-07-21

ApplicantHycel, Inc.
Decision Date1977-07-21
Product Code
DecisionSubstantially Equivalent

Device Summary

CPK-INT TEST is the device name listed in this FDA 510(k) record. The listed applicant is Hycel, Inc.. It received FDA 510(k) clearance on 1977-07-21 under 510(k) number K771154. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CPK-INT TEST?

CPK-INT TEST is a medical device that received FDA 510(k) clearance on 1977-07-21. The listed applicant is Hycel, Inc.. The 510(k) number is K771154.

When did CPK-INT TEST receive FDA 510(k) clearance?

CPK-INT TEST received FDA 510(k) clearance on 1977-07-21, under 510(k) number K771154.

Who is the listed applicant for CPK-INT TEST?

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

Other records listing Hycel, Inc. 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.

K802422HYCEL TRIGYCERIDE II TESTK790335HYCEL MK782116KETOSTEROID TEST, HYCEL-17K782176HYCEL LDH-INT TESTK782100HYCEL COUNTER 333K782102HYCEL COUNTER 211

View all 22 devices →

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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