KODAK EKTACHEM TOTAL IRON-BINDING CAPACITY KIT
FDA 510(k) clearance K931493 · decided 1993-05-26
Clearance details
- K-number
- K931493
- Device name
- KODAK EKTACHEM TOTAL IRON-BINDING CAPACITY KIT
- Applicant
- Eastman Kodak Company
- Decision
- Substantially Equivalent
- Date received
- 1993-03-25
- Decision date
- 1993-05-26
- Days to decision
- 62 days
- Clearance type
- Traditional
- Product code
- JMO
- Device class
- 1
- Regulation number
- 862.1415
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Rochester, NY, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Eastman Kodak Company
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.
Recalls involving this device
No recalls on record reference this clearance.