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 |