510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K933997Substantially Equivalent

Prospect Entamoeba Histolytica Microplate Assay

Alexon Biomedical, Inc., Sunnyvale CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K933997 is the FDA 510(k) clearance record for PROSPECT ENTAMOEBA HISTOLYTICA MICROPLATE ASSAY, a class II device, cleared for Alexon Biomedical, Inc. on under FDA product code GMD (Antisera, Latex Agglutination, Cryptococcus Neoformans). FDA records list 5 510(k) clearances for Alexon Biomedical, Inc., from to . As of , FDA records show no recalls naming K933997.

Clearance record

Decision date
Received
(97 days to decision)
Product code
GMD Antisera, Latex Agglutination, Cryptococcus Neoformans
Regulation
21 CFR 866.3165
Device class
Class II
Review panel
Microbiology
Applicant
Alexon Biomedical, Inc. 1190 Borregas Ave., Sunnyvale CA
510(k) summary
Statement
Third party review
No

Clearances, product code GMD

Trailing 12 months

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

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