The following data is part of a premarket notification filed by Bionetic Laboratory Products with the FDA for Amebiasis Bio-enzabead Screen Kit.
| Device ID | K831133 |
| 510k Number | K831133 |
| Device Name: | AMEBIASIS BIO-ENZABEAD SCREEN KIT |
| Classification | Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. |
| Applicant | BIONETIC LABORATORY PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KHW |
| CFR Regulation Number | 866.3220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-07 |
| Decision Date | 1983-06-08 |