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FDA 510(k)

MODIFICATION TO MYALLERGY TEST

K-Number: K061979 · 2006-09-22

ApplicantImmunetech Corporation
Decision Date2006-09-22
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO MYALLERGY 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 2006-09-22 under 510(k) number K061979. 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 MODIFICATION TO MYALLERGY TEST?

MODIFICATION TO MYALLERGY TEST is a medical device that received FDA 510(k) clearance on 2006-09-22. The listed applicant is Immunetech Corporation. The 510(k) number is K061979.

When did MODIFICATION TO MYALLERGY TEST receive FDA 510(k) clearance?

MODIFICATION TO MYALLERGY TEST received FDA 510(k) clearance on 2006-09-22, under 510(k) number K061979.

Who is the listed applicant for MODIFICATION TO MYALLERGY 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 MODIFICATION TO MYALLERGY TEST?

The FDA product code for MODIFICATION TO MYALLERGY TEST is JKA.

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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.

K032251IMMUNETECH TOTAL IGE SYSTEMK021698MY ALLERGY TESTK020387MYALLERGYTEST 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.

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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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