510(k) K970248
- Device
- CANTROL SERUM IRON AND TOTAL IRON BINDING CAPACITY TEST SYSTEM
- Applicant
- CANYON DIAGNOSTICS, INC.
- 510(k) number
- K970248
- Product code
- JQE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-02-11
- Date received
- 1997-01-22
- Regulation
- 862.1415
- Classification name
- Resin, Ion-exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ANTHONY FALKOWSKI
- Address
- 4075 Leaverton Ct. Anaheim CA US 92807 92807
FDA Registration Numbers#
- 3027555933
Source Documents#
Other 510(k) Records For Product Code JQE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K934358 | KODAK EKTACHEM DT SLIDES (FE) | Eastman Kodak Company | 1994-03-21 |
| K910672 | J&S PEDIATRIC IRON SATURATING REAGENT | J.S. Medical Assoc. | 1991-04-29 |
| K884649 | TOTAL IRON BINDING CAPACITY TEST | Sclavo, Inc. | 1988-12-14 |
| K864548 | ALFERR TIBC TUBE | Benchmark Reagents | 1987-02-02 |
| K842019 | TIBC PRETREATMENT KIT | E.I. Dupont DE Nemours & Co., Inc. | 1984-06-22 |
Legacy Summary#
summary
FDA Review#
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