FJHClass II
Dialyzer, Disposable
21 CFR 876.5830 / Gastroenterology, Urology
FJH is the FDA product code for Dialyzer, Disposable, a class II device type, regulated under 21 CFR 876.5830. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- FJH
- Device name
- Dialyzer, Disposable
- Regulation
- 21 CFR 876.5830
- Device class
- Class II
- Review panel
- Gastroenterology, Urology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- Yes
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 4
- Ingested recalls
- 0
Clearances, product code FJH
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1982 | 1 |
| 1985 | 1 |
| 1986 | 1 |
| 1992 | 1 |
Applicants with the most clearances
Product code FJH| Applicant | Clearances |
|---|---|
| National Medical Care, Medical Products Div., Inc. | 1 |
| Societe D' Analyses Bio-Pharmaceutiques,Inc. | 1 |
| Trans-National Trade Development Corp. | 1 |
| Travenol Laboratories, S.A. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code FJH.
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