KODAK EKTACHEM CLINICAL CHEM. NH3
FDA 510(k) clearance K820723 · decided 1982-04-01
Clearance details
- K-number
- K820723
- Device name
- KODAK EKTACHEM CLINICAL CHEM. NH3
- Applicant
- Eastman Kodak Company
- Decision
- Substantially Equivalent
- Date received
- 1982-03-16
- Decision date
- 1982-04-01
- Days to decision
- 16 days
- Clearance type
- Traditional
- Product code
- JID
- Device class
- 1
- Regulation number
- 862.1065
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, US
- 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 |
|---|---|---|
| CARESIDE AMMONIA (K991371) | Careside, Inc. | 1999-08-03 |
| AMMONIA TEST (K813366) | Wako Pure Chemical Industries, Ltd. | 1981-12-22 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| VITROS Chemistry Products AMON Slides packaged as 300 slides/pack catalog number 1721869 a recall (Z-0297-2014) | Ortho-Clinical Diagnostics | 2013-11-15 |