Combo-Fer Iron Diagnostic
FDA 510(k) K811954 · Immuno Assay Corp.
510(k) numberK811954
Submission
- Device name
- Combo-Fer Iron Diagnostic
- Applicant
- Immuno Assay Corp.
Mchenry, IL, US - Received
- July 8, 1981
- Decision date
- July 27, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JQG – Radiometric, Fe59, Iron Binding Capacity
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1415
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JQG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K800710 | Ferritiron Kit Cat. #RP-1100JQG · Traditional | Ria Products, Inc. | 05/14/1980SE |
| K800868 | Ferro-Quant TM Fe 59 Test KitJQG · Traditional | Mallinckrodt Critical Care | 04/29/1980SE |
| K790133 | SPINSEP-FE59JQG · Traditional | Nuclear Diagnostics, Inc. | 03/02/1979SE |
| K780412 | Total Iron Binding CapacityJQG · Traditional | Diagnostic Corp. of America | 05/26/1978SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K833842 | Ria Coat DigoxinDPO · Traditional | 01/17/1984SE |
| K833745 | Riacoat T-4CDX · Traditional | 01/04/1984SE |
| K820089 | TSH (Ria) KitJLW · Traditional | 01/28/1982SE |
| K820074 | Cortisol (Ria) KitCGR · Traditional | 01/28/1982SE |
| K811725 | TBG Diagnostic KitCEF · Traditional | 07/10/1981SE |
| K811213 | T3 (Ria) KitCDP · Traditional | 05/29/1981SE |
| K811212 | Digoxin (Ria) KitDNL · Traditional | 05/21/1981SE |
| K810857 | T3 Uptake KitKHQ · Traditional | 04/08/1981SE |
| K810811 | T4 Ria KitCDX · Traditional | 04/07/1981SE |
Questions and answers
When was Combo-Fer Iron Diagnostic cleared by the FDA?
Combo-Fer Iron Diagnostic (K811954) received a 510(k) decision of Substantially Equivalent on July 27, 1981, 19 days after the submission was received.
What is the product code of K811954?
The FDA product code is JQG – Radiometric, Fe59, Iron Binding Capacity, a Class I (low risk) device regulated under 21 CFR 862.1415.