Ferritiron Kit Cat. #RP-1100
FDA 510(k) K800710 · Ria Products, Inc.
510(k) numberK800710
Submission
- Device name
- Ferritiron Kit Cat. #RP-1100
- Applicant
- Ria Products, Inc.
Mchenry, IL, US - Received
- March 31, 1980
- Decision date
- May 14, 1980
- 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 |
|---|---|---|---|
| K811954 | Combo-Fer Iron DiagnosticJQG · Traditional | Immuno Assay Corp. | 07/27/1981SE |
| 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 |
More from Diagnostic Corp. of America
| 510(k) | Device | Decision |
|---|---|---|
| K813310 | No-Hoil Combostat II KitCDD · Traditional | 12/17/1981SE |
| K802969 | Cortisol 125-I Radioimmunoassay KitCGR · Traditional | 01/02/1981SE |
| K801579 | Vitamin B12 - No-Boil KitCDD · Traditional | 10/23/1980SE |
| K801578 | Combostat - No-Boil KitCDD · Traditional | 10/23/1980SE |
| K800914 | No-Boil Folate Kit #RP-500CGN · Traditional | 05/08/1980SE |
| K781844 | Ferritin KitJMG · Traditional | 01/10/1979SE |
| K781769 | Iron 59 KitJJA · Traditional | 12/04/1978SE |
| K780148 | Ria for Folates & Vit. B12, Combo KitCGN · Traditional | 03/03/1978SE |
Questions and answers
When was Ferritiron Kit Cat. #RP-1100 cleared by the FDA?
Ferritiron Kit Cat. #RP-1100 (K800710) received a 510(k) decision of Substantially Equivalent on May 14, 1980, 44 days after the submission was received.
What is the product code of K800710?
The FDA product code is JQG – Radiometric, Fe59, Iron Binding Capacity, a Class I (low risk) device regulated under 21 CFR 862.1415.