KHW — Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. Class II
FDA Device Classification
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 |