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 |