510(k) K170728
- Device
- E. HISTOLYTICA QUIK CHEK
- Applicant
- TECHLAB, Inc.
- 510(k) number
- K170728
- Product code
- KHW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-06-07
- Date received
- 2017-03-09
- 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
- Donna T. Link
- Address
- 2001 Kraft Dr. 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 |
|---|---|---|---|
| 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 |
| K844141 | ENTAMOEBA HISTOLYTICA HK-9 ANTIGEN (AXENIC) | Lmd Laboratories | 1984-12-06 |
Legacy Summary#
summary
FDA Review#
Decision Summary