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FDA 510(k)

SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343

K-Number: K013466 · 2001-12-21

ApplicantHelena Laboratories
Decision Date2001-12-21
Product CodeJHO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343 is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 2001-12-21 under 510(k) number K013466. 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 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343?

SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343 is a medical device that received FDA 510(k) clearance on 2001-12-21. The listed applicant is Helena Laboratories. The 510(k) number is K013466.

When did SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343 receive FDA 510(k) clearance?

SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343 received FDA 510(k) clearance on 2001-12-21, under 510(k) number K013466.

Who is the listed applicant for SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343?

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 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343?

The FDA product code for SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343 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, 4103,4123MoraxK010337LIPOPRINT SYSTEM, LDL SUBFRACTIONSQuantimetrix Corp.K000603SPIFE CHOLESTEROL PROFILE 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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