ALFERR TIBC TUBE
FDA 510(k) clearance K864548 · decided 1987-02-02
Clearance details
- K-number
- K864548
- Device name
- ALFERR TIBC TUBE
- Applicant
- Benchmark Reagents
- Decision
- Substantially Equivalent
- Date received
- 1986-11-19
- Decision date
- 1987-02-02
- Days to decision
- 75 days
- Clearance type
- Traditional
- Product code
- JQE
- Device class
- 1
- Regulation number
- 862.1415
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Australia, AU
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CANTROL SERUM IRON AND TOTAL IRON BINDING CAPACITY TEST SYSTEM (K970248) | Canyon Diagnostics, Inc. | 1997-02-11 |
| KODAK EKTACHEM DT SLIDES (FE) (K934358) | Eastman Kodak Company | 1994-03-21 |
| J&S PEDIATRIC IRON SATURATING REAGENT (K910672) | J.S. Medical Assoc. | 1991-04-29 |
| TOTAL IRON BINDING CAPACITY TEST (K884649) | Sclavo, Inc. | 1988-12-14 |
| TIBC PRETREATMENT KIT (K842019) | E.I. Dupont DE Nemours & Co., Inc. | 1984-06-22 |
Recalls involving this device
No recalls on record reference this clearance.