The following data is part of a premarket notification filed by Dana Laboratories with the FDA for Hemodialysis Concentrate Additives.
| Device ID | K851431 |
| 510k Number | K851431 |
| Device Name: | HEMODIALYSIS CONCENTRATE ADDITIVES |
| Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Applicant | DANA LABORATORIES 2700 PETERSON WAY-63C Costa Mesa, CA 92626 |
| Contact | Ronald Goodman |
| Correspondent | Ronald Goodman DANA LABORATORIES 2700 PETERSON WAY-63C Costa Mesa, CA 92626 |
| Product Code | KPO |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-10 |
| Decision Date | 1985-06-12 |