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FDA 510(k)

QUICKELISA ANTHRAX-PA KIT

K-Number: K040407 · 2004-06-03

ApplicantImmunetics, Inc.
Decision Date2004-06-03
Product CodeNRL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

QUICKELISA ANTHRAX-PA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Immunetics, Inc.. It received FDA 510(k) clearance on 2004-06-03 under 510(k) number K040407. The device is classified under product code NRL. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUICKELISA ANTHRAX-PA KIT?

QUICKELISA ANTHRAX-PA KIT is a medical device that received FDA 510(k) clearance on 2004-06-03. The listed applicant is Immunetics, Inc.. The 510(k) number is K040407.

When did QUICKELISA ANTHRAX-PA KIT receive FDA 510(k) clearance?

QUICKELISA ANTHRAX-PA KIT received FDA 510(k) clearance on 2004-06-03, under 510(k) number K040407.

Who is the listed applicant for QUICKELISA ANTHRAX-PA KIT?

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

What is the FDA product code for QUICKELISA ANTHRAX-PA KIT?

The FDA product code for QUICKELISA ANTHRAX-PA KIT is NRL.

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 Immunetics, Inc. 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.

K003754IMMUNETICS C6 LYME ELISA KITK991063QUALICODE B. BURGDORFERI IGG WESTERN BLOT KIT, MODEL DK-C052-024K991062QUALICODE B. BURGDORFERI IGM WESTERN BLOT KIT, MODEL DK-C062-024

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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