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FDA 510(k)

MY ALLERGY TEST

K-Number: K021698 · 2002-09-19

ApplicantImmunetech Corporation
Decision Date2002-09-19
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MY ALLERGY TEST is the device name listed in this FDA 510(k) record. The listed applicant is Immunetech Corporation. It received FDA 510(k) clearance on 2002-09-19 under 510(k) number K021698. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MY ALLERGY TEST?

MY ALLERGY TEST is a medical device that received FDA 510(k) clearance on 2002-09-19. The listed applicant is Immunetech Corporation. The 510(k) number is K021698.

When did MY ALLERGY TEST receive FDA 510(k) clearance?

MY ALLERGY TEST received FDA 510(k) clearance on 2002-09-19, under 510(k) number K021698.

Who is the listed applicant for MY ALLERGY TEST?

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

What is the FDA product code for MY ALLERGY TEST?

The FDA product code for MY ALLERGY TEST is JKA.

Related Clinical Trials

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.

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Other records listing Immunetech Corporation 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.

K061979MODIFICATION TO MYALLERGY TESTK032251IMMUNETECH TOTAL IGE SYSTEMK020387MYALLERGYTEST SYSTEM

Related Devices (Code: JKA)

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.

K262215Profoject™ Safety Sliding Blood Collection SetCMT Health PTE., Ltd.K252899Female Culture Device; Male Culture Device; Transfer Device; Access DeviceZhejiang Kindly Medical Device Co., Ltd.K260128BD Preset™ and BD A-Line™ Arterial Blood Collection SyringesBecton, Dickinson and CompanyK252506BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached HolderBecton, Dickinson and CompanyK252378BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection TubeBecton, Dickinson and CompanyK252040BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection TubesBecton, Dickinson and Company

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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