The following data is part of a premarket notification filed by Serono Laboratories, Inc. with the FDA for Human Placental Lactogen Radioimmuno-.
| Device ID | K810625 |
| 510k Number | K810625 |
| Device Name: | HUMAN PLACENTAL LACTOGEN RADIOIMMUNO- |
| Classification | Ng3m(bo), Antigen, Antiserum, Control |
| Applicant | SERONO LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DHI |
| CFR Regulation Number | 866.5065 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-03-09 |
| Decision Date | 1981-03-27 |