The following data is part of a premarket notification filed by Amuchina Intl., Inc. with the FDA for Amuchina/dialyzer Disinfectant.
| Device ID | K852359 |
| 510k Number | K852359 |
| Device Name: | AMUCHINA/DIALYZER DISINFECTANT |
| Classification | System, Dialysate Delivery, Central Multiple Patient |
| Applicant | AMUCHINA INTL., INC. 1030 FIFTEENTH ST. NW EXECUTIVE BLDG. #720 Washington, DC 20005 |
| Contact | Bernard J Cooney |
| Correspondent | Bernard J Cooney AMUCHINA INTL., INC. 1030 FIFTEENTH ST. NW EXECUTIVE BLDG. #720 Washington, DC 20005 |
| Product Code | FKQ |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-04 |
| Decision Date | 1986-05-13 |