The following data is part of a premarket notification filed by Syn-kit, Inc. with the FDA for Geste Follow Kit Determ. Of Hpl.
| Device ID | K802454 |
| 510k Number | K802454 |
| Device Name: | GESTE FOLLOW KIT DETERM. OF HPL |
| Classification | Radioimmunoassay, Human Placental Lactogen |
| Applicant | SYN-KIT, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JMF |
| CFR Regulation Number | 862.1585 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-10-08 |
| Decision Date | 1980-11-12 |