KODAK EKTACHEM DT 60 ANALYZER
FDA 510(k) clearance K841503 · decided 1984-05-22
Clearance details
- K-number
- K841503
- Device name
- KODAK EKTACHEM DT 60 ANALYZER
- Applicant
- Eastman Kodak Company
- Decision
- Substantially Equivalent
- Date received
- 1984-04-10
- Decision date
- 1984-05-22
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- JJE
- Device class
- 1
- Regulation number
- 862.2160
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- 7600 Ridge Blvd Brooklun, 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
| Record | Firm | Date |
|---|---|---|
| VITROS Chemistry Products GLU DT Slides GEN 56, REF (Catalog #) 153 2316, 25 slides per bo recall (Z-0151-2007) | Ortho-Clinical Diagnostics | 2006-11-04 |
| Vitros Chemistry *** GLU (glucose) DT Slides ***25 slides per box *** CAT 153 2316 *** Ort recall (Z-1225-03) | Ortho-Clinical Diagnostics | 2003-09-11 |