The following data is part of a premarket notification filed by Antibodies Inc. with the FDA for Giardeia(tm).
| Device ID | K890774 |
| 510k Number | K890774 |
| Device Name: | GIARDEIA(TM) |
| Classification | Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. |
| Applicant | ANTIBODIES INC. P.O. BOX 1560 Davis, CA 95617 |
| Contact | Banovitz, Ph.d. |
| Correspondent | Banovitz, Ph.d. ANTIBODIES INC. P.O. BOX 1560 Davis, CA 95617 |
| Product Code | KHW |
| CFR Regulation Number | 866.3220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-15 |
| Decision Date | 1989-04-04 |