FDA Product Code
FDA Product Code KPO — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5820
510(k) Clearances — 124 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K864942 | BICARBONATE MIXING SYSTEM | Morris Tool , Ltd. | 1987-03-10 | Traditional | PDF ↗ |
| K863631 | SODIUM BICARBONATE POWDER/BICARBONATE HEMODIALYSIS | American Healthcare Corp. | 1986-10-16 | Traditional | PDF ↗ |
| K861156 | HOSPAL DIALYSATE FOR CAVHD | Hospal Medical Corp. | 1986-09-23 | Traditional | PDF ↗ |
| K852955 | HEMOD CONCE OF VAR FORMU & LIPUID HEMOD CONCE ADD | Renalchem, Inc. | 1986-02-05 | Traditional | PDF ↗ |
| K854206 | ULTRACLONE 05-100 GUINEA PIG RBC | Earl-Clay Laboratories, Inc. | 1985-10-31 | Traditional | PDF ↗ |
| K851431 | HEMODIALYSIS CONCENTRATE ADDITIVES | Dana Laboratories | 1985-06-12 | Traditional | PDF ↗ |
| K843866 | HEMODIALYSATE SOLUTIONS | Bicarbolyte Corp. | 1985-01-09 | Traditional | PDF ↗ |
| K834538 | LAS-2 ALIGNMENT SYSTEM | Therados, Inc. | 1984-02-21 | Traditional | PDF ↗ |
| K832866 | HEMO-DIAL | Cmi Pharmaceuticals, Inc. | 1983-11-03 | Traditional | PDF ↗ |
| K823779 | DIALYTE | Renal Dynamics, Inc. | 1983-01-17 | Traditional | PDF ↗ |
| K823103 | DIALYSATE ADDITIVES-POWDER/LIQUID | Di-Chem, Inc. | 1982-11-17 | Traditional | PDF ↗ |
| K821304 | CENTRALYTE BICARBONATE CONCENTRATE | Erika, Inc. | 1982-05-18 | Traditional | PDF ↗ |
| K813586 | DIALYSIS CONCENTRATE | Diversified Medical Services | 1982-01-29 | Traditional | PDF ↗ |
| K820150 | K-AID | Sytek Laboratories | 1982-01-29 | Traditional | PDF ↗ |
| K813388 | HEMODIALYSATE | Edlaw Pharmaceuticals, Inc. | 1981-12-31 | Traditional | PDF ↗ |
| K811706 | LACTIC ACID DIALYSATE ADDITIVE | Edlaw Pharmaceuticals, Inc. | 1981-09-24 | Traditional | PDF ↗ |
| K810925 | NATURALYTE BICARBONATE DIALYSATE CONCEN. | Erika, Inc. | 1981-04-23 | Traditional | PDF ↗ |
| K810527 | CHEM-DIALYTE CONCENTRATES | Luchem Pharmaceuticals, Inc. | 1981-04-23 | Traditional | PDF ↗ |
| K810280 | DIALYSATE CONCENTRATE FOR HEMODIALYSIS | Cobe Laboratories, Inc. | 1981-02-19 | Traditional | PDF ↗ |
| K800624 | LOW-ACETATE HEMODIALYSIS BATH CONCENTR. | Travenol Laboratories, S.A. | 1980-07-14 | Traditional | PDF ↗ |
| K792513 | HEMODIALYSIS CONCENTRATE SOLUTION | Mid Atlantic Nephrology Center | 1980-04-08 | Traditional | PDF ↗ |
| K792213 | RENAL SYSTEMS HEMODIALYSIS CONCENTRATE | Renal Systems, Inc. | 1980-01-04 | Traditional | PDF ↗ |
| K781967 | HEMODIALYSIS CONCENTRATE, SODIU | Renal Systems, Inc. | 1978-12-07 | Traditional | PDF ↗ |
| K780353 | DRI-LYTE | Mallinckrodt Critical Care | 1978-04-05 | Traditional | PDF ↗ |
Product code KPO · Class II · Gastroenterology, Urology. Data: openFDA.