510(k) K944791
- Device
- ENTAMOEBA TEST
- Applicant
- TECHLAB, INC.
- 510(k) number
- K944791
- Product code
- KHW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-03-09
- Date received
- 1994-09-28
- Regulation
- 866.3220
- Classification name
- Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- PATRICIA SHRADER
- Address
- 1861 Pratt Dr. Corporate Research Center Blacksburg VA US 24060 24060
FDA Registration Numbers#
- 3022178699
- 3011527950
- 3002800697
- 3005360469
- 3008191245
- 3007208259
- 1122855
- 3009935129
- 3003718445
- 3024463179
- 2245285
- 3026241718
Source Documents#
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 |
| 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 |
| K844141 | ENTAMOEBA HISTOLYTICA HK-9 ANTIGEN (AXENIC) | Lmd Laboratories | 1984-12-06 |
| K831133 | AMEBIASIS BIO-ENZABEAD SCREEN KIT | Bionetic Laboratory Products | 1983-06-08 |
Legacy Summary#
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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