510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K040407Substantially Equivalent

Quickelisa Anthrax-Pa Kit

Immunetics, Inc., Boston MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K040407 is the FDA 510(k) clearance record for QUICKELISA ANTHRAX-PA KIT, a class II device, cleared for Immunetics, Inc. on under FDA product code NRL (Enzyme Linked Immunoabsorbent Assay, Antibody, B. Anthracis). FDA's definition for product code NRL reads: "The elisa assay for antibodies to b. Anthracis is used to detect an immunological response to proteins secreted by b. Anthracis; As an aid in the laboratory diagnosis of anthrax". FDA records list 4 510(k) clearances for Immunetics, Inc., from to . As of , FDA records show no recalls naming K040407.

Clearance record

Decision date
Received
(107 days to decision)
Product code
NRL Enzyme Linked Immunoabsorbent Assay, Antibody, B. Anthracis
Regulation
21 CFR 866.3045
Device class
Class II
Review panel
Microbiology
Applicant
Immunetics, Inc. 27 Drydock Ave., Boston MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NRL

Trailing 12 months

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

FDA records show no clearances under product code NRL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NRL, 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