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 |