510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K982315Substantially Equivalent

Prospect Campylobacter Microplate Assay

Alexon - Trend, Inc., Ramsey MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K982315 is the FDA 510(k) clearance record for PROSPECT CAMPYLOBACTER MICROPLATE ASSAY, a class I device, cleared for Alexon - Trend, Inc. on under FDA product code LQP (Campylobacter Spp.). FDA records list 3 510(k) clearances for Alexon - Trend, Inc., from to . As of , FDA records show one recall naming K982315.

Clearance record

Decision date
Received
(140 days to decision)
Product code
LQP Campylobacter Spp.
Regulation
21 CFR 866.3110
Device class
Class I
Review panel
Microbiology
Applicant
Alexon - Trend, Inc. 14000 Unity St. NW, Ramsey MN
510(k) summary
Statement
Third party review
No

Clearances, product code LQP

Trailing 12 months

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

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