510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K980507Substantially Equivalent

Prospect Shiga Toxin Microplate Assay

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

K980507 is the FDA 510(k) clearance record for PROSPECT SHIGA TOXIN MICROPLATE ASSAY, a class I device, cleared for Alexon - Trend, Inc. on under FDA product code GMZ (Antigens, All Types, Escherichia Coli). FDA records list 3 510(k) clearances for Alexon - Trend, Inc., from to . As of , FDA records show one recall naming K980507.

Clearance record

Decision date
Received
(72 days to decision)
Product code
GMZ Antigens, All Types, Escherichia Coli
Regulation
21 CFR 866.3255
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 GMZ

Trailing 12 months

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

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