510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K863270Substantially Equivalent

Gene-Trak Campylobacter Assay

Integrated Genetics, Framingham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863270 is the FDA 510(k) clearance record for GENE-TRAK CAMPYLOBACTER ASSAY, a class I device, cleared for Integrated Genetics on under FDA product code LQO (Dna-Reagents, Campylobacter Spp.). FDA records list one 510(k) clearance for Integrated Genetics. As of , FDA records show no recalls naming K863270.

Clearance record

Decision date
Received
(371 days to decision)
Product code
LQO Dna-Reagents, Campylobacter Spp.
Regulation
21 CFR 866.3110
Device class
Class I
Review panel
Microbiology
Applicant
Integrated Genetics 32 New York Ave., Framingham MA
Third party review
No

Clearances, product code LQO

Trailing 12 months

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

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