Panels › Gastroenterology, Urology › Product code FKJ · Class 2
Filter, Blood, Dialysis
Regulation 876.5820
1510(k)s in 12 months (5 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in FKJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Serim Research | 2 | 0 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 0 |
| Computer Dialysis Systems, Inc. | 1 | 0 |
| Terumo America, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 17, 2026 | K253863 | GUARDIAN Quick Dip Residual Chlorine (5212) Serim Research | FKJ |
| Sep 13, 1990 | K901734 | SERIM RESIDUAL CHLORINE TEST KIT Serim Research Corp. | FKJ |
| May 14, 1984 | K841307 | BBL GASPAK POUCH Bd Becton Dickinson Vacutainer Systems Preanalytic | FKJ |
| May 20, 1982 | K820575 | J.E.T. DIALYSIS SYSTEM Computer Dialysis Systems, Inc. | FKJ |
| Nov 28, 1977 | K772040 | TRANSDUCER PROTECTOR Terumo America, Inc. | FKJ |
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