The following data is part of a premarket notification filed by Mission Pharmacal Co. with the FDA for Urocystin.
| Device ID | K843382 |
| 510k Number | K843382 |
| Device Name: | UROCYSTIN |
| Classification | Nitroprusside Reaction (qualitative, Urine), Cystine |
| Applicant | MISSION PHARMACAL CO. P.O. BOX 1676 San Antonio, TX 78296 |
| Contact | George Alexandrides |
| Correspondent | George Alexandrides MISSION PHARMACAL CO. P.O. BOX 1676 San Antonio, TX 78296 |
| Product Code | JLC |
| CFR Regulation Number | 862.1240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-28 |
| Decision Date | 1985-01-08 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() UROCYSTIN 73484415 1358685 Dead/Cancelled |
SANTEN PHARMACEUTICAL CO., LTD. 1984-06-11 |