FDA product code KHW: Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
KHW is the FDA product code for antigen, id, ha, cep, entamoeba histolytica & rel. spp.. It is a Class II device, regulated under 21 CFR 866.3220 and reviewed by the Microbiology panel. FDA has cleared 18 510(k) submissions under KHW, from 10 different applicants. The average 510(k) review took 87 days (median 46).
Classification
| Field | Value |
|---|---|
| Device name | Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. |
| Device class | Class II |
| Regulation | 21 CFR 866.3220 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
510(k) clearances per year for KHW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 90 |
Compare with all 510(k) review times · Search every KHW clearance
Top KHW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Lmd Laboratories | 5 | 1989-03-14 |
| Techlab, Inc. | 4 | 2017-06-07 |
| Diamedix Corp. | 2 | 1986-10-09 |
| Trend Scientific, Inc. | 1 | 1996-08-08 |
| Biovir Laboratories, Inc. | 1 | 1990-07-26 |
5 more applicants have KHW clearances. See the full list in Caduvo.
Most recent KHW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K170728 | Techlab, Inc. | E. HISTOLYTICA QUIK CHEK | 2017-06-07 | 90 |
| K994101 | Techlab, Inc. | E. HISTOLYTICA II | 1999-12-21 | 15 |
| K955895 | Techlab, Inc. | E. HISTOLYTICA TEST | 1996-08-30 | 248 |
| K954996 | Trend Scientific, Inc. | TREND AMEBIASIS (E.HISTOLYTICA) SEROLOGICAL ELISA TEST SYSTEM | 1996-08-08 | 281 |
| K944791 | Techlab, Inc. | ENTAMOEBA TEST | 1995-03-09 | 162 |
Recalls for KHW devices
openFDA lists no recalls for product code KHW.
Frequently asked questions
What is FDA product code KHW?
KHW is the FDA product code for antigen, id, ha, cep, entamoeba histolytica & rel. spp.. It is a Class II device, regulated under 21 CFR 866.3220 and reviewed by the Microbiology panel.
What device class is KHW?
Class II, regulation 21 CFR 866.3220. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KHW?
Across 18 cleared submissions the average was 87 days from receipt to decision (median 46).
Which companies have the most KHW clearances?
Lmd Laboratories (5); Techlab, Inc. (4); Diamedix Corp. (2); Trend Scientific, Inc. (1); Biovir Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KHW
- Run a recall and safety report across every KHW manufacturer
- Watch product code KHW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Microbiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times