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

Antigen, Id, Candida Albicans

21 CFR 866.3165 / Microbiology
FDA source (opens on fda.gov)

LHK is the FDA product code for Antigen, Id, Candida Albicans, a class II device type, regulated under 21 CFR 866.3165. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
LHK
Device name
Antigen, Id, Candida Albicans
Regulation
21 CFR 866.3165
Device class
Class II
Review panel
Microbiology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
1

Clearances, product code LHK

By decision year
4 clearances under product code LHK with a decision year between 1981 and 1989, 1981 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code LHK by decision year
YearClearances
19812
19821
19891

Applicants with the most clearances

Product code LHK
Applicants holding the most 510(k) clearances under product code LHK
ApplicantClearances
American Scientific Products1
BD Becton Dickinson Vacutainer Systems Preanalytic1
Nolan Biological Laboratories, Inc.1
Ramco Laboratories, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code