The following data is part of a premarket notification filed by Schiff & Co. with the FDA for Beta-hcg Assay.
| Device ID | K873986 |
| 510k Number | K873986 |
| Device Name: | BETA-HCG ASSAY |
| Classification | System, Test, Human Chorionic Gonadotropin |
| Applicant | SCHIFF & CO. 1129 BLOOMFIELD AVE. West Caldwell, NJ 07006 |
| Contact | Kafader Ii |
| Correspondent | Kafader Ii SCHIFF & CO. 1129 BLOOMFIELD AVE. West Caldwell, NJ 07006 |
| Product Code | DHA |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-29 |
| Decision Date | 1988-02-02 |