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FDA 510(k)

MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123

K-Number: K012789 · 2002-01-17

ApplicantMorax
Decision Date2002-01-17
Product CodeJHO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123 is the device name listed in this FDA 510(k) record. The listed applicant is Morax. It received FDA 510(k) clearance on 2002-01-17 under 510(k) number K012789. 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 MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123?

MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123 is a medical device that received FDA 510(k) clearance on 2002-01-17. The listed applicant is Morax. The 510(k) number is K012789.

When did MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123 receive FDA 510(k) clearance?

MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123 received FDA 510(k) clearance on 2002-01-17, under 510(k) number K012789.

Who is the listed applicant for MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123?

The FDA 510(k) record lists Morax as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123?

The FDA product code for MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123 is JHO.

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Other records listing Morax 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.

K033277HYDRAGEL CSF ISOFOCUSING KITSK992148HYDRAGEL-MINI ISO-CK KIT, HYDRAGEL ISO-CK KIT, HYDRAGEL 7 IS0-CK KIT, HYDRAGEL ISO-CK 15/30 KITK991362HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO)K990250HYDRAGEL LDL/HDL CHOL DIRECT KIT-P.N. 4005, HYDRAGEL 7 LDL/HDL CHOL DIRECT KIT-P.N. 4103, HYDRAGEL LDL/HDL CHOL DIRECT 0K981048HYDRAGEL 6 CSF KITK974854HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KIT-PN 4207

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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.K013466SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343Helena LaboratoriesK010337LIPOPRINT 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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