Dialyzer, Magniflo 100 Parallel Plate
FDA 510(k) K781966 · Erika, Inc.
510(k) numberK781966
Submission
- Device name
- Dialyzer, Magniflo 100 Parallel Plate
- Applicant
- Erika, Inc.
Mchenry, IL, US - Received
- November 24, 1978
- Decision date
- February 21, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FJG – Dialyzer, Parallel Flow
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
Other 510(k)s with product code FJG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K933681 | Gambro Lundia Pro 100, 500, 600 DialyzersFJG · Traditional | Cobe Renal Care, Inc. | 09/07/1994SE |
| K933680 | Gambro Lundia Pro 200 DialyzerFJG · Traditional | Cobe Renal Care, Inc. | 08/26/1994SE |
| K920693 | Dextrolyte II Peritoneal Dialysis 48-3028-9FJG · Traditional | National Medical Care, Medical Products Div., Inc. | 09/21/1992SE |
| K915504 | Gambro Lundia Alpha HemodialyzersFJG · Traditional | C.G.H. Medical, Inc. | 03/06/1992SE |
| K901368 | Hemospal Kits A1, A2D, Ao, & A1DFJG · Traditional | Gambro-Hospal, Inc. | 08/02/1990SE |
| K902203 | Tenckhoff Peritoneal Dialysis KitFJG · Traditional | Akcess Medical Products, Inc. | 08/01/1990SESK |
| K862840 | Gambro Lundia 10-1L, 1N, 1H, 3H, 4N, 4H, 5H, 6NFJG · Traditional | Gambro, Inc. | 09/29/1986SE |
| K853406 | Gambro Lundia Pro 3 & 5 DialyzerFJG · Traditional | Gambro, Inc. | 01/08/1986SE |
| K820694 | Cobe PPD 1.3L, #18-520-009FJG · Traditional | Cobe Laboratories, Inc. | 03/31/1982SE |
| K812336 | Cobe PPD 1.9FJG · Traditional | Cobe Laboratories, Inc. | 08/31/1981SE |
More from Cobe Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K853134 | National Med Care Infusion Pump Adm Set #95-0001-8FRN · Traditional | 11/06/1985SE |
| K852310 | Naturalyte Bicarbonate Concentrate-Dry PackFKQ · Traditional | 07/26/1985SE |
| K852309 | Erika Art Li, 3-9621-8, 22-6, 23-4 & Ven 9714-1FJK · Traditional | 07/26/1985SE |
| K850866 | Toray Industries Filtryzer Hollow Fiber Kidney B1LKDI · Traditional | 04/03/1985SE |
| K850865 | Toray Industries Filtryzer Hollow Fiber Kidney B1-FJI · Traditional | 04/03/1985SE |
| K850655 | Toray Ind. Filtryzer Hollow Fiber Artif. Kidney B2FJI · Traditional | 03/07/1985SE |
| K850654 | Toray Indus. Filtryzer Hollow Fiber Artificial KidFJI · Traditional | 03/07/1985SE |
| K842436 | Erika Negative Press. Arterial BloodKOC · Traditional | 07/13/1984SE |
| K831176 | Filtryzer Hollow Fiber Artif. KidneyKOC · Traditional | 06/22/1984SE |
| K831175 | Filtryzer Hollow Fiber Artif. KidneyKOC · Traditional | 06/22/1984SE |
Questions and answers
When was Dialyzer, Magniflo 100 Parallel Plate cleared by the FDA?
Dialyzer, Magniflo 100 Parallel Plate (K781966) received a 510(k) decision of Substantially Equivalent on February 21, 1979, 89 days after the submission was received.
What is the product code of K781966?
The FDA product code is FJG – Dialyzer, Parallel Flow, a Class II (moderate risk) device regulated under 21 CFR 876.5820.