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FDA 510(k)

SPIFE CHOLESTEROL PROFILE KIT

K-Number: K000603 · 2000-04-17

ApplicantHelena Laboratories
Decision Date2000-04-17
Product CodeJHO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SPIFE CHOLESTEROL PROFILE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 2000-04-17 under 510(k) number K000603. 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 SPIFE CHOLESTEROL PROFILE KIT?

SPIFE CHOLESTEROL PROFILE KIT is a medical device that received FDA 510(k) clearance on 2000-04-17. The listed applicant is Helena Laboratories. The 510(k) number is K000603.

When did SPIFE CHOLESTEROL PROFILE KIT receive FDA 510(k) clearance?

SPIFE CHOLESTEROL PROFILE KIT received FDA 510(k) clearance on 2000-04-17, under 510(k) number K000603.

Who is the listed applicant for SPIFE CHOLESTEROL PROFILE KIT?

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 SPIFE CHOLESTEROL PROFILE KIT?

The FDA product code for SPIFE CHOLESTEROL PROFILE KIT is JHO.

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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

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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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