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FDA 510(k)

LFS LIPOGEL ASSAY KIT

K-Number: K960785 · 1996-09-03

ApplicantZaxis, Inc.
Decision Date1996-09-03
Product CodeJHO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LFS LIPOGEL ASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Zaxis, Inc.. It received FDA 510(k) clearance on 1996-09-03 under 510(k) number K960785. 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 LFS LIPOGEL ASSAY KIT?

LFS LIPOGEL ASSAY KIT is a medical device that received FDA 510(k) clearance on 1996-09-03. The listed applicant is Zaxis, Inc.. The 510(k) number is K960785.

When did LFS LIPOGEL ASSAY KIT receive FDA 510(k) clearance?

LFS LIPOGEL ASSAY KIT received FDA 510(k) clearance on 1996-09-03, under 510(k) number K960785.

Who is the listed applicant for LFS LIPOGEL ASSAY KIT?

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

What is the FDA product code for LFS LIPOGEL ASSAY KIT?

The FDA product code for LFS LIPOGEL ASSAY KIT is JHO.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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