510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K863499Substantially Equivalent

Candidate(r) Super

Mercia Diagnostics, Ltd., Guildford, Surrey England, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863499 is the FDA 510(k) clearance record for CANDIDATE(R) SUPER, a class II device, cleared for Mercia Diagnostics , Ltd. on under FDA product code LRF (Candida Spp., Direct Antigen, Id). FDA records list 17 510(k) clearances for Mercia Diagnostics , Ltd., from to . As of , FDA records show no recalls naming K863499.

Clearance record

Decision date
Received
(191 days to decision)
Product code
LRF Candida Spp., Direct Antigen, Id
Regulation
21 CFR 866.3165
Device class
Class II
Review panel
Microbiology
Applicant
Mercia Diagnostics , Ltd. Mercia Houseet, Guildford, Surrey England, GB
Third party review
No

Clearances, product code LRF

Trailing 12 months

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

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