The following data is part of a premarket notification filed by Catachem, Inc. with the FDA for Uric Acid (uricase) Method-ii.
Device ID | K863287 |
510k Number | K863287 |
Device Name: | URIC ACID (URICASE) METHOD-II |
Classification | Acid, Uric, Uricase (oxygen Rate) |
Applicant | CATACHEM, INC. 6 NORTH PEARL ST. Port Chester, NY 10573 |
Contact | Luis P Leon |
Correspondent | Luis P Leon CATACHEM, INC. 6 NORTH PEARL ST. Port Chester, NY 10573 |
Product Code | JHC |
CFR Regulation Number | 862.1775 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-08-25 |
Decision Date | 1986-09-29 |