The following data is part of a premarket notification filed by Althin Biopharm, Inc. with the FDA for Acid Concentrate And Powder, Acetate Concentrate Liquid And Powder, And Bicarbonate Concentrate Liquid And Powder.
| Device ID | K990507 |
| 510k Number | K990507 |
| Device Name: | ACID CONCENTRATE AND POWDER, ACETATE CONCENTRATE LIQUID AND POWDER, AND BICARBONATE CONCENTRATE LIQUID AND POWDER |
| Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Applicant | ALTHIN BIOPHARM, INC. 3885 INDUSTRIAL BLVD. Laval, Quebec, CA H7l 4s3 |
| Contact | Jean Sauriol |
| Correspondent | Jean Sauriol ALTHIN BIOPHARM, INC. 3885 INDUSTRIAL BLVD. Laval, Quebec, CA H7l 4s3 |
| Product Code | KPO |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-18 |
| Decision Date | 1999-05-07 |