Panels › Microbiology › Product code KHW · Class 2
Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
Regulation 866.3220
0510(k)s in 12 months (18 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in KHW
| Company | 510(k)s | Recalls |
|---|---|---|
| Lmd Laboratories | 5 | 0 |
| Techlab, Inc. | 4 | 0 |
| Diamedix Corp. | 2 | 0 |
| Alexon Biomedical, Inc. | 1 | 0 |
| Antibodies, Inc. | 1 | 0 |
| Bionetic Laboratory Products | 1 | 0 |
| Biovir Laboratories, Inc. | 1 | 0 |
| Cordis Corp. | 1 | 0 |
| Hillcrest Biologicals | 1 | 0 |
| Trend Scientific, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 7, 2017 | K170728 | E. HISTOLYTICA QUIK CHEK Techlab, Inc. | KHW |
| Dec 21, 1999 | K994101 | E. HISTOLYTICA II Techlab, Inc. | KHW |
| Aug 30, 1996 | K955895 | E. HISTOLYTICA TEST Techlab, Inc. | KHW |
| Aug 8, 1996 | K954996 | TREND AMEBIASIS (E.HISTOLYTICA) SEROLOGICAL ELISA TEST SYSTEM Trend Scientific, Inc. | KHW |
| Mar 9, 1995 | K944791 | ENTAMOEBA TEST Techlab, Inc. | KHW |
| Jul 26, 1990 | K900604 | DIRECT FLUORESCENT ANTIBODY REAGENT FOR GIARDIA Biovir Laboratories, Inc. | KHW |
| Apr 4, 1989 | K890774 | GIARDEIA(TM) Antibodies, Inc. | KHW |
| Mar 14, 1989 | K890003 | GIARDIA STOOL ANTIGEN TEST KIT Lmd Laboratories | KHW |
| Jan 5, 1988 | K874849 | PROSPECT/GIARDIA Alexon Biomedical, Inc. | KHW |
| Aug 11, 1987 | K870318 | AMEBIASIS ELISA TEST KIT Lmd Laboratories | KHW |
| Oct 9, 1986 | K863811 | AMEBIASIS MICROASSAY Diamedix Corp. | KHW |
| Aug 1, 1986 | K862473 | PDQ AMEBIASIS Diamedix Corp. | KHW |
| Nov 12, 1985 | K854230 | MEBIASIS AGAR GEL DIFFUSION KIT Lmd Laboratories | KHW |
| Oct 22, 1985 | K854017 | ENTAMOEBA HISTOLYTICA-POSITIVE CONTROL(RABBIT) Lmd Laboratories | KHW |
| Aug 28, 1985 | K853448 | HILLCREST AMEBIASIS IHA TEST Hillcrest Biologicals | KHW |
| Dec 6, 1984 | K844141 | ENTAMOEBA HISTOLYTICA HK-9 ANTIGEN (AXENIC) Lmd Laboratories | KHW |
| Jun 8, 1983 | K831133 | AMEBIASIS BIO-ENZABEAD SCREEN KIT Bionetic Laboratory Products | KHW |
| Feb 25, 1981 | K810046 | CORDIA A Cordis Corp. | KHW |
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