The following data is part of a premarket notification filed by Adeza Biomedical with the FDA for Oba(tm) Serum Hcg Assay.
| Device ID | K911047 |
| 510k Number | K911047 |
| Device Name: | OBA(TM) SERUM HCG ASSAY |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | ADEZA BIOMEDICAL 1240 ELKO DR. Sunnyvale, CA 94089 |
| Contact | Yuh-geng Tsay |
| Correspondent | Yuh-geng Tsay ADEZA BIOMEDICAL 1240 ELKO DR. Sunnyvale, CA 94089 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-08 |
| Decision Date | 1991-06-24 |