KHW — Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. Class II
FDA product code KHW covers "Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.", a Class II medical device regulated under 21 CFR 866.3220. Submissions are reviewed by the Microbiology panel. At least 18 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KHW
- Device Class
- Class II
- Regulation Number
- 866.3220
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K170728 | techlab | E. HISTOLYTICA QUIK CHEK | June 7, 2017 |
| K994101 | techlab | E. HISTOLYTICA II | December 21, 1999 |
| K955895 | techlab | E. HISTOLYTICA TEST | August 30, 1996 |
| K954996 | trend scientific | TREND AMEBIASIS (E.HISTOLYTICA) SEROLOGICAL ELISA TEST SYSTEM | August 8, 1996 |
| K944791 | techlab | ENTAMOEBA TEST | March 9, 1995 |
| K900604 | biovir laboratories | DIRECT FLUORESCENT ANTIBODY REAGENT FOR GIARDIA | July 26, 1990 |
| K890774 | antibodies | GIARDEIA(TM) | April 4, 1989 |
| K890003 | lmd laboratories | GIARDIA STOOL ANTIGEN TEST KIT | March 14, 1989 |
| K874849 | alexon biomedical | PROSPECT/GIARDIA | January 5, 1988 |
| K870318 | lmd laboratories | AMEBIASIS ELISA TEST KIT | August 11, 1987 |
| K863811 | diamedix | AMEBIASIS MICROASSAY | October 9, 1986 |
| K862473 | diamedix | PDQ AMEBIASIS | August 1, 1986 |
| K854230 | lmd laboratories | MEBIASIS AGAR GEL DIFFUSION KIT | November 12, 1985 |
| K854017 | lmd laboratories | ENTAMOEBA HISTOLYTICA-POSITIVE CONTROL(RABBIT) | October 22, 1985 |
| K853448 | hillcrest biologicals | HILLCREST AMEBIASIS IHA TEST | August 28, 1985 |
| K844141 | lmd laboratories | ENTAMOEBA HISTOLYTICA HK-9 ANTIGEN (AXENIC) | December 6, 1984 |
| K831133 | bionetic laboratory products | AMEBIASIS BIO-ENZABEAD SCREEN KIT | June 8, 1983 |
| K810046 | cordis | CORDIA A | February 25, 1981 |