510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K030370Substantially Equivalent

Redline Anthrax Alert Test

Tetracore, Inc, Gaithersburg, MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K030370 is the FDA 510(k) clearance record for REDLINE ANTHRAX ALERT TEST, a class II device, cleared for Tetracore, Inc. on under FDA product code NPO (Kit, Immunochromatographic, Bacillus Anthracis Differential Antibody). FDA's definition for product code NPO reads: "A serological reagent to distinguish b. Anthracis culture growth from other bacillus spp. Growth". FDA records list one 510(k) clearance for Tetracore, Inc. As of , FDA records show no recalls naming K030370.

Clearance record

Decision date
Received
(308 days to decision)
Product code
NPO Kit, Immunochromatographic, Bacillus Anthracis Differential Antibody
Regulation
21 CFR 866.3045
Device class
Class II
Review panel
Microbiology
Applicant
Tetracore, Inc. 11 Firstfield Rd., Gaithersburg, MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NPO

Trailing 12 months

FDA records hold no clearances under product code NPO in the trailing twelve months.

FDA records show no clearances under product code NPO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NPO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260