Iron 59 Kit
FDA 510(k) K781769 · Ria Products, Inc.
510(k) numberK781769
Submission
- Device name
- Iron 59 Kit
- Applicant
- Ria Products, Inc.
Mchenry, IL, US - Received
- October 16, 1978
- Decision date
- December 4, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJA – Radio-Labeled Iron Method, Iron (Non-Heme)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1410
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JJA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K820253 | Simul-Fer Serum Iron Test KitJJA · Traditional | Diagnostic Reagents, Inc. | 05/12/1982SE |
| K782159 | Diagnostic Kit, FERRITAB-FE-59JJA · Traditional | Leeco Diagnostics, Inc. | 02/01/1979SE |
| K760045 | Kit, Radioassay, Serum IronJJA · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 07/20/1976SE |
More from Bd Becton Dickinson Vacutainer Systems Preanalytic
| 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 |
| K800710 | Ferritiron Kit Cat. #RP-1100JQG · Traditional | 05/14/1980SE |
| K800914 | No-Boil Folate Kit #RP-500CGN · Traditional | 05/08/1980SE |
| K781844 | Ferritin KitJMG · Traditional | 01/10/1979SE |
| K780148 | Ria for Folates & Vit. B12, Combo KitCGN · Traditional | 03/03/1978SE |
Questions and answers
When was Iron 59 Kit cleared by the FDA?
Iron 59 Kit (K781769) received a 510(k) decision of Substantially Equivalent on December 4, 1978, 49 days after the submission was received.
What is the product code of K781769?
The FDA product code is JJA – Radio-Labeled Iron Method, Iron (Non-Heme), a Class I (low risk) device regulated under 21 CFR 862.1410.