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
K823016Substantially Equivalent

Candida Detection System

Ramco Laboratories, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K823016 is the FDA 510(k) clearance record for CANDIDA DETECTION SYSTEM, a class II device, cleared for Ramco Laboratories, Inc. on under FDA product code LHK (Antigen, Id, Candida Albicans). FDA records list 9 510(k) clearances for Ramco Laboratories, Inc., from to . As of , FDA records show no recalls naming K823016.

Clearance record

Decision date
Received
(77 days to decision)
Product code
LHK Antigen, Id, Candida Albicans
Regulation
21 CFR 866.3165
Device class
Class II
Review panel
Microbiology
Applicant
Ramco Laboratories, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code LHK

Trailing 12 months

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

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