MODIFICATION OF EMIT AND AMIKACIN ASSAY
FDA 510(k) clearance K833546 · decided 1983-12-08
Clearance details
- K-number
- K833546
- Device name
- MODIFICATION OF EMIT AND AMIKACIN ASSAY
- Applicant
- Syva Co.
- Decision
- Substantially Equivalent
- Date received
- 1983-10-14
- Decision date
- 1983-12-08
- Days to decision
- 55 days
- Clearance type
- Traditional
- Product code
- LDN
- Device class
- 2
- Regulation number
- 862.3035
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- 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 |
|---|---|---|
| AMIKACIN REAGENT TEST KIT (K840647) | Beckman Instruments, Inc. | 1984-04-02 |
| EMIT-AMD AMIKACIN CONTR. (ENZYME IMMUNO (K820440) | Syva Co. | 1982-03-15 |
Recalls involving this device
No recalls on record reference this clearance.