Total Iron Binding Capacity Test
FDA 510(k) K884649 · Sclavo, Inc.
510(k) numberK884649
Submission
- Device name
- Total Iron Binding Capacity Test
- Applicant
- Sclavo, Inc.
Wayne, NJ, US - Received
- November 7, 1988
- Decision date
- December 14, 1988
- 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
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|---|---|---|---|
| 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 |
| K864548 | Alferr Tibc TubeJQE · Traditional | Benchmark Reagents | 02/02/1987SE |
| K842019 | Tibc Pretreatment KitJQE · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 06/22/1984SE |
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Questions and answers
When was Total Iron Binding Capacity Test cleared by the FDA?
Total Iron Binding Capacity Test (K884649) received a 510(k) decision of Substantially Equivalent on December 14, 1988, 37 days after the submission was received.
What is the product code of K884649?
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.