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FDA 510(k)

REDLINE ANTHRAX ALERT TEST

K-Number: K030370 · 2003-12-09

ApplicantTetracore, Inc.
Decision Date2003-12-09
Product CodeNPO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

REDLINE ANTHRAX ALERT TEST is the device name listed in this FDA 510(k) record. The listed applicant is Tetracore, Inc.. It received FDA 510(k) clearance on 2003-12-09 under 510(k) number K030370. The device is classified under product code NPO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REDLINE ANTHRAX ALERT TEST?

REDLINE ANTHRAX ALERT TEST is a medical device that received FDA 510(k) clearance on 2003-12-09. The listed applicant is Tetracore, Inc.. The 510(k) number is K030370.

When did REDLINE ANTHRAX ALERT TEST receive FDA 510(k) clearance?

REDLINE ANTHRAX ALERT TEST received FDA 510(k) clearance on 2003-12-09, under 510(k) number K030370.

Who is the listed applicant for REDLINE ANTHRAX ALERT TEST?

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

What is the FDA product code for REDLINE ANTHRAX ALERT TEST?

The FDA product code for REDLINE ANTHRAX ALERT TEST is NPO.

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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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