The following data is part of a premarket notification filed by Catachem, Inc. with the FDA for Albumin (bcg) For Continuous Flow Instruments.
| Device ID | K874163 |
| 510k Number | K874163 |
| Device Name: | ALBUMIN (BCG) FOR CONTINUOUS FLOW INSTRUMENTS |
| Classification | Bromcresol Green Dye-binding, Albumin |
| 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 | CIX |
| CFR Regulation Number | 862.1035 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-13 |
| Decision Date | 1987-11-23 |