EMIT AND NETILMICIN ASSAY
FDA 510(k) clearance K820324 · decided 1982-02-23
Clearance details
- K-number
- K820324
- Device name
- EMIT AND NETILMICIN ASSAY
- Applicant
- Syva Co.
- Decision
- Substantially Equivalent
- Date received
- 1982-02-05
- Decision date
- 1982-02-23
- Days to decision
- 18 days
- Clearance type
- Traditional
- Product code
- LCE
- Device class
- 2
- Regulation number
- 862.3450
- 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 |
|---|---|---|
| EMIT NETILMICIN ASSAY (K833715) | Syva Co. | 1983-12-27 |
| AMES TDA NETILMICIN TEST & SERUM (K832088) | Miles Laboratories, Inc. | 1983-10-28 |
| NETILMICIN FLUORESCENT IMMUNOASSAY (K822941) | American Diagnostic Corp. | 1982-10-26 |
| TDX NETILMICIN (K821698) | Abbott Laboratories | 1982-06-22 |
| MACRO-VUE CARD TEST, NETILMICIN (K821399) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1982-05-28 |
Recalls involving this device
No recalls on record reference this clearance.