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FDA 510(k)

REP ULTRA HDL,VLDL/LDL CHOLESTEROL SYSTEM

K-Number: K904035 · 1990-11-09

ApplicantHelena Laboratories
Decision Date1990-11-09
Product CodeLBT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REP ULTRA HDL,VLDL/LDL CHOLESTEROL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1990-11-09 under 510(k) number K904035. The device is classified under product code LBT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REP ULTRA HDL,VLDL/LDL CHOLESTEROL SYSTEM?

REP ULTRA HDL,VLDL/LDL CHOLESTEROL SYSTEM is a medical device that received FDA 510(k) clearance on 1990-11-09. The listed applicant is Helena Laboratories. The 510(k) number is K904035.

When did REP ULTRA HDL,VLDL/LDL CHOLESTEROL SYSTEM receive FDA 510(k) clearance?

REP ULTRA HDL,VLDL/LDL CHOLESTEROL SYSTEM received FDA 510(k) clearance on 1990-11-09, under 510(k) number K904035.

Who is the listed applicant for REP ULTRA HDL,VLDL/LDL CHOLESTEROL SYSTEM?

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 ULTRA HDL,VLDL/LDL CHOLESTEROL SYSTEM?

The FDA product code for REP ULTRA HDL,VLDL/LDL CHOLESTEROL SYSTEM is LBT.

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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.

K131479V8 SP NORMAL CONTROL, ABNORMAL CONTROLK100103SPECIALTY ASSAYED CONTROL-2K061991PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACAK061069SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458K061014ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LPK050053HEMORAM/AGGRAM ANALYZER

View all 280 devices →

Related Devices (Code: LBT)

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.

K000568HDL CHOLESTEROL PLUSRoche Diagnostics Corp.K990250HYDRAGEL LDL/HDL CHOL DIRECT KIT-P.N. 4005, HYDRAGEL 7 LDL/HDL CHOL DIRECT KIT-P.N. 4103, HYDRAGEL LDL/HDL CHOL DIRECT 0MoraxK972015HYDRAGEL 7,15,30, CHOL-HDL KITMoraxK894366REP HDL-8 KIT, NO. 3188, REP HDL-16 KIT, NO. 3187Helena LaboratoriesK882368REP HDL ELECTROPHORESIS METHODHelena LaboratoriesK873547TITAN GEL HDL CHOLESTEROL KITHelena Laboratories

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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