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 |