CANTROL SERUM IRON AND TOTAL IRON BINDING CAPACITY TEST SYSTEM
FDA 510(k) clearance K970248 · decided 1997-02-11
Clearance details
- K-number
- K970248
- Device name
- CANTROL SERUM IRON AND TOTAL IRON BINDING CAPACITY TEST SYSTEM
- Applicant
- Canyon Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-01-22
- Decision date
- 1997-02-11
- Days to decision
- 20 days
- Clearance type
- Traditional
- Product code
- JQE
- Device class
- 1
- Regulation number
- 862.1415
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Anaheim, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Canyon Diagnostics
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 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 |
| ALFERR TIBC TUBE (K864548) | Benchmark Reagents | 1987-02-02 |
| 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.