The following data is part of a premarket notification filed by Wampole Laboratories with the FDA for One-step Hcg.
| Device ID | K882896 |
| 510k Number | K882896 |
| Device Name: | ONE-STEP HCG |
| Classification | System, Test, Human Chorionic Gonadotropin |
| Applicant | WAMPOLE LABORATORIES P.O. BOX NO. 1 Cranbury, NJ 08512 |
| Contact | Ann Maclearie |
| Correspondent | Ann Maclearie WAMPOLE LABORATORIES P.O. BOX NO. 1 Cranbury, NJ 08512 |
| Product Code | DHA |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-11 |
| Decision Date | 1988-10-31 |