AMMONIA TEST
FDA 510(k) clearance K813366 · decided 1981-12-22
Clearance details
- K-number
- K813366
- Device name
- AMMONIA TEST
- Applicant
- Wako Pure Chemical Industries, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1981-11-30
- Decision date
- 1981-12-22
- Days to decision
- 22 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 |
| KODAK EKTACHEM CLINICAL CHEM. NH3 (K820723) | Eastman Kodak Company | 1982-04-01 |
Recalls involving this device
No recalls on record reference this clearance.