510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K936191Substantially Equivalent

Prospect Cryptosporidium Rapid Assay

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

K936191 is the FDA 510(k) clearance record for PROSPECT CRYPTOSPORIDIUM RAPID ASSAY, a class II device, cleared for Alexon Biomedical, Inc. on under FDA product code MHJ (Cryptosporidium Spp.). FDA records list 5 510(k) clearances for Alexon Biomedical, Inc., from to . As of , FDA records show no recalls naming K936191.

Clearance record

Decision date
Received
(329 days to decision)
Product code
MHJ Cryptosporidium Spp.
Regulation
21 CFR 866.3220
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 MHJ

Trailing 12 months

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

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