The following data is part of a premarket notification filed by Diasol, Inc. with the FDA for Diasol-additives.
| Device ID | K020231 |
| 510k Number | K020231 |
| Device Name: | DIASOL-ADDITIVES |
| Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Applicant | DIASOL, INC. 13212 RAYMER ST. North Hollywood, CA 91605 |
| Contact | Monica Abeles |
| Correspondent | Monica Abeles DIASOL, INC. 13212 RAYMER ST. North Hollywood, CA 91605 |
| Product Code | KPO |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-23 |
| Decision Date | 2002-10-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B467PC98145 | K020231 | 000 |
| B467CC313115 | K020231 | 000 |
| B467CC31170 | K020231 | 000 |
| B467CC157145 | K020231 | 000 |
| B467CC125120 | K020231 | 000 |
| B467CC113145 | K020231 | 000 |
| B467CC102145 | K020231 | 000 |
| B467CAG504 | K020231 | 000 |
| B467AA64 | K020231 | 000 |
| B467CC51220 | K020231 | 000 |
| B467CC57170 | K020231 | 000 |
| B467CC63170 | K020231 | 000 |
| B467PC63170 | K020231 | 000 |
| B467PC58170 | K020231 | 000 |
| B467PC159145 | K020231 | 000 |
| B467PC127120 | K020231 | 000 |
| B467PC115145 | K020231 | 000 |
| B467PC104145 | K020231 | 000 |
| B467MG86 | K020231 | 000 |
| B467CC97145 | K020231 | 000 |
| B467AA20260 | K020231 | 000 |