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FDA 510(k)

LYOPHILIZED HDL CHOLESTEROL CONTROLS

K-Number: K792025 · 1979-10-30

ApplicantHelena Laboratories
Decision Date1979-10-30
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LYOPHILIZED HDL CHOLESTEROL CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1979-10-30 under 510(k) number K792025. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LYOPHILIZED HDL CHOLESTEROL CONTROLS?

LYOPHILIZED HDL CHOLESTEROL CONTROLS is a medical device that received FDA 510(k) clearance on 1979-10-30. The listed applicant is Helena Laboratories. The 510(k) number is K792025.

When did LYOPHILIZED HDL CHOLESTEROL CONTROLS receive FDA 510(k) clearance?

LYOPHILIZED HDL CHOLESTEROL CONTROLS received FDA 510(k) clearance on 1979-10-30, under 510(k) number K792025.

Who is the listed applicant for LYOPHILIZED HDL CHOLESTEROL CONTROLS?

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

What is the FDA product code for LYOPHILIZED HDL CHOLESTEROL CONTROLS?

The FDA product code for LYOPHILIZED HDL CHOLESTEROL CONTROLS is JJY.

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Other records listing Helena Laboratories 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: JJY)

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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