The following data is part of a premarket notification filed by Diasol, Inc. with the FDA for Dryasol Acid Concentrate Mix.
| Device ID | K993212 |
| 510k Number | K993212 |
| Device Name: | DRYASOL ACID CONCENTRATE MIX |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-24 |
| Decision Date | 1999-10-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B467ACP453257510016 | K993212 | 000 |
| B467ACP452257520025 | K993212 | 000 |
| B467ACP452257510016 | K993212 | 000 |
| B467ACP451257510016 | K993212 | 000 |
| B467ACP362351020025 | K993212 | 000 |
| B467ACP362251020025 | K993212 | 000 |
| B467ACP362201020025 | K993212 | 000 |
| B467ACP352251010025 | K993212 | 000 |