Elvi Total Iron Binding Capacity
FDA 510(k) K792409 · Volu Sol Medical Industries
510(k) numberK792409
Submission
- Device name
- Elvi Total Iron Binding Capacity
- Applicant
- Volu Sol Medical Industries
Mchenry, IL, US - Received
- November 26, 1979
- Decision date
- December 6, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JQF – Bathophenanthroline, Iron Binding Capacity
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1415
- Specialty
- Clinical Chemistry
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| K875176 | Wako(Tm) UibcJQF · Traditional | Wako Chemicals USA, Inc. | 02/02/1988SE |
| K863066 | TransfermeterJQF · Traditional | J. D. Assoc. | 12/04/1986SE |
| K830032 | Total Iron Binding Capacity TestJQF · Traditional | Sclavo, Inc. | 01/28/1983SE |
| K811942 | J & S Iron Saturating ReagentJQF · Traditional | Thyroid Diagnostics, Inc. | 09/08/1981SE |
| K810086 | Iron & TicbJQF · Traditional | Bio-Analytics Laboratories, Inc. | 01/28/1981SE |
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| K822036 | Volu-Sol DecalciferKDX · Traditional | 08/03/1982SE |
| K822035 | Volu-Sol Gills EaHZJ · Traditional | 08/03/1982SE |
| K812906 | Elvi Biclot 816KQG · Traditional | 07/22/1982SE |
| K821541 | Hematoxylin IIIHYJ · Traditional | 06/10/1982SE |
Questions and answers
When was Elvi Total Iron Binding Capacity cleared by the FDA?
Elvi Total Iron Binding Capacity (K792409) received a 510(k) decision of Substantially Equivalent on December 6, 1979, 10 days after the submission was received.
What is the product code of K792409?
The FDA product code is JQF – Bathophenanthroline, Iron Binding Capacity, a Class I (low risk) device regulated under 21 CFR 862.1415.