Alferr Tibc Tube
FDA 510(k) K864548 · Benchmark Reagents
510(k) numberK864548
Submission
- Device name
- Alferr Tibc Tube
- Applicant
- Benchmark Reagents
Australia, AU - Received
- November 19, 1986
- Decision date
- February 2, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JQE – Resin, Ion-Exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1415
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JQE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K970248 | Cantrol Serum Iron and Total Iron Binding Capacity Test SystemJQE · Traditional | Canyon Diagnostics, Inc. | 02/11/1997SE |
| K934358 | Kodak Ektachem DT Slides (Fe)JQE · Traditional | Eastman Kodak Company | 03/21/1994SE |
| K910672 | J&S Pediatric Iron Saturating ReagentJQE · Traditional | J.S. Medical Assoc. | 04/29/1991SE |
| K884649 | Total Iron Binding Capacity TestJQE · Traditional | Sclavo, Inc. | 12/14/1988SE |
| K842019 | Tibc Pretreatment KitJQE · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 06/22/1984SE |
Questions and answers
When was Alferr Tibc Tube cleared by the FDA?
Alferr Tibc Tube (K864548) received a 510(k) decision of Substantially Equivalent on February 2, 1987, 75 days after the submission was received.
What is the product code of K864548?
The FDA product code is JQE – Resin, Ion-Exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity, a Class I (low risk) device regulated under 21 CFR 862.1415.