FDA Product Code
FDA Product Code FHS — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5820
510(k) Clearances — 12 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K812811 | MICROCOIL 80 DIALYZER | Erika, Inc. | 1981-12-03 | Traditional | PDF ↗ |
| K811974 | MICROCOIL 150 DIALYZER | Erika, Inc. | 1981-09-16 | Traditional | PDF ↗ |
| K801634 | THE VITA 2 DISPOSABLE DIALYZER | Bellco Artifidial Organ Spec., Inc. | 1980-12-17 | Traditional | PDF ↗ |
| K800723 | MICRO-COIL 100 COIL DIALYZER | Erika, Inc. | 1980-05-14 | Traditional | PDF ↗ |
| K800174 | GAMBRO LUNDIA COIL DIALYZER | Gambro, Inc. | 1980-02-13 | Traditional | PDF ↗ |
| K790223 | DIALYZER, CD-800 COIL | Travenol Laboratories, S.A. | 1979-03-26 | Traditional | PDF ↗ |
| K781102 | DIALYZER, DISP., COIL, LUNDIA | Gambro, Inc. | 1978-10-17 | Traditional | PDF ↗ |
| K771349 | MODIFICATION TO KIDNEY DIALYZER | Erika, Inc. | 1977-08-02 | Traditional | PDF ↗ |
| K770735 | DIALYZER, COIL, CD, LSA, 5M1765 | Travenol Laboratories, S.A. | 1977-05-10 | Traditional | PDF ↗ |
| K761358 | COIL DIALYZER MODEL ALT 140 | Bentley Laboratories, Inc. | 1977-01-10 | Traditional | PDF ↗ |
| K760702 | ERI-FLO 900 DIALYZER | Erika, Inc. | 1976-11-19 | Traditional | PDF ↗ |
| K760374 | DIALYZER (MODEL 1850) | Erika, Inc. | 1976-10-27 | Traditional | PDF ↗ |
Product code FHS · Class II · Gastroenterology, Urology. Data: openFDA.