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FDA 510(k)

REP CHOLESTEROL PROFILE CONTROL

K-Number: K950590 · 1995-03-30

ApplicantHelena Laboratories
Decision Date1995-03-30
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REP CHOLESTEROL PROFILE CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1995-03-30 under 510(k) number K950590. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REP CHOLESTEROL PROFILE CONTROL?

REP CHOLESTEROL PROFILE CONTROL is a medical device that received FDA 510(k) clearance on 1995-03-30. The listed applicant is Helena Laboratories. The 510(k) number is K950590.

When did REP CHOLESTEROL PROFILE CONTROL receive FDA 510(k) clearance?

REP CHOLESTEROL PROFILE CONTROL received FDA 510(k) clearance on 1995-03-30, under 510(k) number K950590.

Who is the listed applicant for REP CHOLESTEROL PROFILE CONTROL?

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 REP CHOLESTEROL PROFILE CONTROL?

The FDA product code for REP CHOLESTEROL PROFILE CONTROL is JJX.

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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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