510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K812741Substantially Equivalent

Reagents for Serodiagnosis of Candidosis

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

K812741 is the FDA 510(k) clearance record for REAGENTS FOR SERODIAGNOSIS OF CANDIDOSIS, a class II device, cleared for Nolan Biological Laboratories, Inc. on under FDA product code LHK (Antigen, Id, Candida Albicans). FDA records list 5 510(k) clearances for Nolan Biological Laboratories, Inc., from to . As of , FDA records show no recalls naming K812741.

Clearance record

Decision date
Received
(24 days to decision)
Product code
LHK Antigen, Id, Candida Albicans
Regulation
21 CFR 866.3165
Device class
Class II
Review panel
Microbiology
Applicant
Nolan Biological 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