The following data is part of a premarket notification filed by Catachem, Inc. with the FDA for Alkaline Phosphatase (ap) For Cont. Flow Instru..
| Device ID | K871543 |
| 510k Number | K871543 |
| Device Name: | ALKALINE PHOSPHATASE (AP) FOR CONT. FLOW INSTRU. |
| Classification | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes |
| 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 | CJE |
| CFR Regulation Number | 862.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-20 |
| Decision Date | 1987-06-22 |