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FDA 510(k)

CHOLESTEROL (TOTAL) ANALYSIS PRODUCTS

K-Number: K870928 · 1987-04-22

ApplicantElectro-Nucleonics Laboratories, Inc.
Decision Date1987-04-22
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHOLESTEROL (TOTAL) ANALYSIS PRODUCTS is the device name listed in this FDA 510(k) record. The listed applicant is Electro-Nucleonics Laboratories, Inc.. It received FDA 510(k) clearance on 1987-04-22 under 510(k) number K870928. 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 (TOTAL) ANALYSIS PRODUCTS?

CHOLESTEROL (TOTAL) ANALYSIS PRODUCTS is a medical device that received FDA 510(k) clearance on 1987-04-22. The listed applicant is Electro-Nucleonics Laboratories, Inc.. The 510(k) number is K870928.

When did CHOLESTEROL (TOTAL) ANALYSIS PRODUCTS receive FDA 510(k) clearance?

CHOLESTEROL (TOTAL) ANALYSIS PRODUCTS received FDA 510(k) clearance on 1987-04-22, under 510(k) number K870928.

Who is the listed applicant for CHOLESTEROL (TOTAL) ANALYSIS PRODUCTS?

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

What is the FDA product code for CHOLESTEROL (TOTAL) ANALYSIS PRODUCTS?

The FDA product code for CHOLESTEROL (TOTAL) ANALYSIS PRODUCTS is CHH.

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Other records listing Electro-Nucleonics Laboratories, Inc. 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.

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