FDA Product Code
FDA Product Code FLB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5820
510(k) Clearances — 6 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K100237 | DIALYSATE METER, MODEL D-6 | Myron L Company | 2010-04-23 | Traditional | PDF ↗ |
| K925210 | 90DX MULTITEST METER, MODIFICATION | Mesa Medical, Inc. | 1994-01-25 | Traditional | PDF ↗ |
| K882032 | MODEL 90DX MULTITEST METER | Mesa Medical, Inc. | 1988-08-11 | Traditional | PDF ↗ |
| K830629 | COBE RX METER | Cobe Laboratories, Inc. | 1983-04-06 | Traditional | PDF ↗ |
| K821415 | MODEL 90 BC | Western Laboratories Corp. | 1982-05-27 | Traditional | PDF ↗ |
| K770263 | DIALYSATE METER RS-2100A, CIRCUIT CHANGE | Renal Systems, Inc. | 1977-02-18 | Traditional | PDF ↗ |
Product code FLB · Class II · Gastroenterology, Urology. Data: openFDA.