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 |