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FDA 510(k)

REP CHOLESTEROL PROFILE TEMPLATE-30, -16, -8; REP VIS CHOLESTEROL

K-Number: K980650 · 1998-05-01

ApplicantHelena Laboratories
Decision Date1998-05-01
Product CodeJHO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REP CHOLESTEROL PROFILE TEMPLATE-30, -16, -8; REP VIS CHOLESTEROL is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1998-05-01 under 510(k) number K980650. The device is classified under product code JHO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REP CHOLESTEROL PROFILE TEMPLATE-30, -16, -8; REP VIS CHOLESTEROL?

REP CHOLESTEROL PROFILE TEMPLATE-30, -16, -8; REP VIS CHOLESTEROL is a medical device that received FDA 510(k) clearance on 1998-05-01. The listed applicant is Helena Laboratories. The 510(k) number is K980650.

When did REP CHOLESTEROL PROFILE TEMPLATE-30, -16, -8; REP VIS CHOLESTEROL receive FDA 510(k) clearance?

REP CHOLESTEROL PROFILE TEMPLATE-30, -16, -8; REP VIS CHOLESTEROL received FDA 510(k) clearance on 1998-05-01, under 510(k) number K980650.

Who is the listed applicant for REP CHOLESTEROL PROFILE TEMPLATE-30, -16, -8; REP VIS CHOLESTEROL?

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 TEMPLATE-30, -16, -8; REP VIS CHOLESTEROL?

The FDA product code for REP CHOLESTEROL PROFILE TEMPLATE-30, -16, -8; REP VIS CHOLESTEROL is JHO.

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Other records listing Helena Laboratories as applicant

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Related Devices (Code: JHO)

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.

K022333SPIFE LIPPOROTEIN-12, MODEL 3344Helena LaboratoriesK022053HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134SebiaK013662MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONSQuantimetrix Corp.K012789MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123MoraxK013466SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343Helena LaboratoriesK010337LIPOPRINT SYSTEM, LDL SUBFRACTIONSQuantimetrix Corp.

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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