The following data is part of a premarket notification filed by Advanced Renal Technologies, Inc. with the FDA for Citrasate Dialysate Acid Concentrate Liquid, Models Cs-1xxx-xx, Cs-xxx-xx, Cs-3xxx-xx.
| Device ID | K000792 |
| 510k Number | K000792 |
| Device Name: | CITRASATE DIALYSATE ACID CONCENTRATE LIQUID, MODELS CS-1XXX-XX, CS-XXX-XX, CS-3XXX-XX |
| Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Applicant | ADVANCED RENAL TECHNOLOGIES, INC. 11838 N.E. 112TH ST. Kirkland, WA 98033 |
| Contact | Robin Callan |
| Correspondent | Robin Callan ADVANCED RENAL TECHNOLOGIES, INC. 11838 N.E. 112TH ST. Kirkland, WA 98033 |
| Product Code | KPO |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-10 |
| Decision Date | 2000-06-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840861101382 | K000792 | 000 |
| 00840861101375 | K000792 | 000 |
| 00840861101368 | K000792 | 000 |
| 10840861101358 | K000792 | 000 |
| 10840861101341 | K000792 | 000 |
| 10840861101334 | K000792 | 000 |