The following data is part of a premarket notification filed by Diasol, Inc. with the FDA for Diasol-bicarb.
| Device ID | K020230 |
| 510k Number | K020230 |
| Device Name: | DIASOL-BICARB |
| 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 | 2002-04-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B467LB80004 | K020230 | 000 |
| B467BP3510T3 | K020230 | 000 |
| B467BP3512 | K020230 | 000 |
| B467BP361T24 | K020230 | 000 |
| B467BP3610T2 | K020230 | 000 |
| B467BP451T24 | K020230 | 000 |
| B467BP4510 | K020230 | 000 |
| B467BP4512 | K020230 | 000 |
| B467BP4515G3 | K020230 | 000 |
| B467BP4525 | K020230 | 000 |
| B467LB100004 | K020230 | 000 |
| B467LB78004 | K020230 | 000 |
| B467BP3501T24 | K020230 | 000 |