510(k) K831133
- Device
- AMEBIASIS BIO-ENZABEAD SCREEN KIT
- Applicant
- BIONETIC LABORATORY PRODUCTS
- 510(k) number
- K831133
- Product code
- KHW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-06-08
- Date received
- 1983-04-07
- Regulation
- 866.3220
- Classification name
- Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
- Medical specialty
- Microbiology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3007208259
- 3003718445
- 3005360469
- 3024463179
- 3026241718
- 1122855
- 3009935129
- 3011527950
- 3022178699
- 3008191245
- 2245285
- 3002800697
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KHW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K170728 | E. HISTOLYTICA QUIK CHEK | Techlab, Inc. | 2017-06-07 |
| K994101 | E. HISTOLYTICA II | Techlab, Inc. | 1999-12-21 |
| K955895 | E. HISTOLYTICA TEST | Techlab, Inc. | 1996-08-30 |
| K954996 | TREND AMEBIASIS (E.HISTOLYTICA) SEROLOGICAL ELISA TEST SYSTEM | Trend Scientific, Inc. | 1996-08-08 |
| K944791 | ENTAMOEBA TEST | Techlab, Inc. | 1995-03-09 |
| K900604 | DIRECT FLUORESCENT ANTIBODY REAGENT FOR GIARDIA | Biovir Laboratories, Inc. | 1990-07-26 |
| K890774 | GIARDEIA(TM) | Antibodies, Inc. | 1989-04-04 |
| K890003 | GIARDIA STOOL ANTIGEN TEST KIT | Lmd Laboratories | 1989-03-14 |
| K874849 | PROSPECT/GIARDIA | Alexon Biomedical, Inc. | 1988-01-05 |
| K870318 | AMEBIASIS ELISA TEST KIT | Lmd Laboratories | 1987-08-11 |
| K863811 | AMEBIASIS MICROASSAY | Diamedix Corp. | 1986-10-09 |
| K862473 | PDQ AMEBIASIS | Diamedix Corp. | 1986-08-01 |
| K854230 | MEBIASIS AGAR GEL DIFFUSION KIT | Lmd Laboratories | 1985-11-12 |
| K854017 | ENTAMOEBA HISTOLYTICA-POSITIVE CONTROL(RABBIT) | Lmd Laboratories | 1985-10-22 |
| K853448 | HILLCREST AMEBIASIS IHA TEST | Hillcrest Biologicals | 1985-08-28 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases