Kodak Ektachem DT Slides (Fe)
FDA 510(k) K934358 · Eastman Kodak Company
510(k) numberK934358
Submission
- Device name
- Kodak Ektachem DT Slides (Fe)
- Applicant
- Eastman Kodak Company
Rochester, NY, US - Received
- September 8, 1993
- Decision date
- March 21, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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
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|---|---|---|---|
| K970248 | Cantrol Serum Iron and Total Iron Binding Capacity Test SystemJQE · Traditional | Canyon Diagnostics, Inc. | 02/11/1997SE |
| 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 |
| 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 Kodak Ektachem DT Slides (Fe) cleared by the FDA?
Kodak Ektachem DT Slides (Fe) (K934358) received a 510(k) decision of Substantially Equivalent on March 21, 1994, 194 days after the submission was received.
What is the product code of K934358?
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.