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 |