Panels › Gastroenterology, Urology › Product code FLB · Class 2
Meter, Conductivity, Induction, Remote Type
Regulation 876.5820
0510(k)s in 12 months (6 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in FLB
| Company | 510(k)s | Recalls |
|---|---|---|
| Mesa Medical, Inc. | 2 | 0 |
| Cobe Laboratories, Inc. | 1 | 0 |
| Myron L Company | 1 | 0 |
| Renal Systems, Inc. | 1 | 0 |
| Western Laboratories Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 23, 2010 | K100237 | DIALYSATE METER, MODEL D-6 Myron L Company | FLB |
| Jan 25, 1994 | K925210 | 90DX MULTITEST METER, MODIFICATION Mesa Medical, Inc. | FLB |
| Aug 11, 1988 | K882032 | MODEL 90DX MULTITEST METER Mesa Medical, Inc. | FLB |
| Apr 6, 1983 | K830629 | COBE RX METER Cobe Laboratories, Inc. | FLB |
| May 27, 1982 | K821415 | MODEL 90 BC Western Laboratories Corp. | FLB |
| Feb 18, 1977 | K770263 | DIALYSATE METER RS-2100A, CIRCUIT CHANGE Renal Systems, Inc. | FLB |
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