510(k) K864548
- Device
- ALFERR TIBC TUBE
- Applicant
- Benchmark Reagents
- 510(k) number
- K864548
- Product code
- JQE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-02-02
- Date received
- 1986-11-19
- 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
- Third party reviewed
- No
Applicant Contact#
- Contact
- STARR
- Address
- 74 Baillie St. Horsham 3400, Victoria Australia AU
FDA Registration Numbers#
- 3027555933
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JQE#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K970248 | CANTROL SERUM IRON AND TOTAL IRON BINDING CAPACITY TEST SYSTEM | Canyon Diagnostics, Inc. | 1997-02-11 |
| 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 |
| K842019 | TIBC PRETREATMENT KIT | E.I. Dupont DE Nemours & Co., Inc. | 1984-06-22 |