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FDA 510(k)

CHOLESTEROL TEST

K-Number: K770265 · 1977-02-25

ApplicantSclavo, Inc.
Decision Date1977-02-25
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHOLESTEROL TEST is the device name listed in this FDA 510(k) record. The listed applicant is Sclavo, Inc.. It received FDA 510(k) clearance on 1977-02-25 under 510(k) number K770265. The device is classified under product code CHH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHOLESTEROL TEST?

CHOLESTEROL TEST is a medical device that received FDA 510(k) clearance on 1977-02-25. The listed applicant is Sclavo, Inc.. The 510(k) number is K770265.

When did CHOLESTEROL TEST receive FDA 510(k) clearance?

CHOLESTEROL TEST received FDA 510(k) clearance on 1977-02-25, under 510(k) number K770265.

Who is the listed applicant for CHOLESTEROL TEST?

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

What is the FDA product code for CHOLESTEROL TEST?

The FDA product code for CHOLESTEROL TEST is CHH.

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Related Devices (Code: CHH)

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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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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