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
KHWClass II

Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.

21 CFR 866.3220 / Microbiology
FDA source (opens on fda.gov)

KHW is the FDA product code for Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp., a class II device type, regulated under 21 CFR 866.3220. As of , FDA records hold 18 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KHW
Device name
Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
Regulation
21 CFR 866.3220
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
18
Ingested recalls
0

Clearances, product code KHW

By decision year
18 clearances under product code KHW with a decision year between 1981 and 2017, 1985 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code KHW by decision year
YearClearances
19811
19831
19841
19853
19862
19871
19881
19892
19901
19951
19962
19991
20171

Applicants with the most clearances

Product code KHW
Applicants holding the most 510(k) clearances under product code KHW
ApplicantClearances
Lmd Laboratories5
Techlab, Inc.4
Diamedix Corp.2
Alexon Biomedical, Inc.1
Antibodies, Inc.1
Bionetic Laboratory Products1
Biovir Laboratories, Inc.1
Cordis US Corp.1
Hillcrest Biologicals1
Trend Scientific, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code