The following data is part of a premarket notification filed by Elias U.s.a., Inc. with the FDA for Synelisa Progesterone.
| Device ID | K933128 |
| 510k Number | K933128 |
| Device Name: | SYNELISA PROGESTERONE |
| Classification | Radioimmunoassay, Progesterone |
| Applicant | ELIAS U.S.A., INC. 373 280TH ST. Osceola, WI 54020 |
| Contact | Gottfried Kellermann |
| Correspondent | Gottfried Kellermann ELIAS U.S.A., INC. 373 280TH ST. Osceola, WI 54020 |
| Product Code | JLS |
| CFR Regulation Number | 862.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-28 |
| Decision Date | 1993-11-05 |