The following data is part of a premarket notification filed by Trend Scientific, Inc. with the FDA for Trend Amebiasis (e.histolytica) Serological Elisa Test System.
| Device ID | K954996 |
| 510k Number | K954996 |
| Device Name: | TREND AMEBIASIS (E.HISTOLYTICA) SEROLOGICAL ELISA TEST SYSTEM |
| Classification | Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. |
| Applicant | TREND SCIENTIFIC, INC. 368 WEST COUNTY RD. D New Brighton, MN 55112 |
| Contact | Mariellyn Truax |
| Correspondent | Mariellyn Truax TREND SCIENTIFIC, INC. 368 WEST COUNTY RD. D New Brighton, MN 55112 |
| Product Code | KHW |
| CFR Regulation Number | 866.3220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-01 |
| Decision Date | 1996-08-08 |
| Summary: | summary |