Product code KHW— Microbiology
AMEBIASIS BIO-ENZABEAD SCREEN KIT
- Classification name
- Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
- Device class
- Class 2
- Regulation
- 21 CFR 866.3220
- Advisory panel
- Microbiology
- Total cleared
- 18
- First cleared
- Most recent
Market context for product code KHW
FDA has cleared devices under product code KHW between 1981 and 2017, filed by 10 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2017
- 1999
- 1996
- 1995
- 1990
- 1989
- 1988
- 1987
- 1986
- 1985
- 1984
- 1983
- 1981
Top applicants under product code KHW
Recent clearances under product code KHW
- K170728 — E. HISTOLYTICA QUIK CHEK
- K994101 — E. HISTOLYTICA II
- K955895 — E. HISTOLYTICA TEST
- K954996 — TREND AMEBIASIS (E.HISTOLYTICA) SEROLOGICAL ELISA TEST SYSTEM
- K944791 — ENTAMOEBA TEST
- K900604 — DIRECT FLUORESCENT ANTIBODY REAGENT FOR GIARDIA
- K890774 — GIARDEIA(TM)
- K890003 — GIARDIA STOOL ANTIGEN TEST KIT
- K874849 — PROSPECT/GIARDIA
- K870318 — AMEBIASIS ELISA TEST KIT
- K863811 — AMEBIASIS MICROASSAY
- K862473 — PDQ AMEBIASIS
- K854230 — MEBIASIS AGAR GEL DIFFUSION KIT
- K854017 — ENTAMOEBA HISTOLYTICA-POSITIVE CONTROL(RABBIT)
- K853448 — HILLCREST AMEBIASIS IHA TEST
- K844141 — ENTAMOEBA HISTOLYTICA HK-9 ANTIGEN (AXENIC)
- K831133 — AMEBIASIS BIO-ENZABEAD SCREEN KIT
- K810046 — CORDIA A
Data sourced from openFDA. This site is unofficial and independent of the FDA.