The following data is part of a premarket notification filed by Biovir Laboratories, Inc. with the FDA for Direct Fluorescent Antibody Reagent For Giardia.
Device ID | K900604 |
510k Number | K900604 |
Device Name: | DIRECT FLUORESCENT ANTIBODY REAGENT FOR GIARDIA |
Classification | Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. |
Applicant | BIOVIR LABORATORIES, INC. 685 STONE RD., UNIT 6 Benicia, CA 94510 |
Contact | Riggs, Phd |
Correspondent | Riggs, Phd BIOVIR LABORATORIES, INC. 685 STONE RD., UNIT 6 Benicia, CA 94510 |
Product Code | KHW |
CFR Regulation Number | 866.3220 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-02-08 |
Decision Date | 1990-07-26 |