The following data is part of a premarket notification filed by Diasol, Inc. with the FDA for Citrisol Acid Concentrate.
| Device ID | K130511 |
| 510k Number | K130511 |
| Device Name: | CITRISOL ACID CONCENTRATE |
| Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Applicant | DIASOL, INC. 1110 Arroyo St San Fernando, CA 91340 |
| Contact | Monica Abeles |
| Correspondent | Monica Abeles DIASOL, INC. 1110 Arroyo St San Fernando, CA 91340 |
| Product Code | KPO |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-27 |
| Decision Date | 2014-02-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B467CSP4522575100 | K130511 | 000 |
| B467CS100125101004 | K130511 | 000 |
| B467CS1002251010055 | K130511 | 000 |
| B467CS100225751004 | K130511 | 000 |
| B467CS100325101004 | K130511 | 000 |
| B467CS100330101004 | K130511 | 000 |
| B467CS80225102004 | K130511 | 000 |
| B467CSP352251010025 | K130511 | 000 |
| B467CSP451257510016 | K130511 | 000 |
| B467CS100000101004 | K130511 | 000 |