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FDA 510(k)

REP CHOLESTEROL PROFILE CONTROL-II

K-Number: K974609 · 1998-01-06

ApplicantHelena Laboratories
Decision Date1998-01-06
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REP CHOLESTEROL PROFILE CONTROL-II is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1998-01-06 under 510(k) number K974609. 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-II?

REP CHOLESTEROL PROFILE CONTROL-II is a medical device that received FDA 510(k) clearance on 1998-01-06. The listed applicant is Helena Laboratories. The 510(k) number is K974609.

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

REP CHOLESTEROL PROFILE CONTROL-II received FDA 510(k) clearance on 1998-01-06, under 510(k) number K974609.

Who is the listed applicant for REP CHOLESTEROL PROFILE CONTROL-II?

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-II?

The FDA product code for REP CHOLESTEROL PROFILE CONTROL-II 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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