EMIT ASSAY AND TOBRAMYCIN
FDA 510(k) clearance K832055 · decided 1983-08-08
Clearance details
- K-number
- K832055
- Device name
- EMIT ASSAY AND TOBRAMYCIN
- Applicant
- Syva Co.
- Decision
- Substantially Equivalent
- Date received
- 1983-06-27
- Decision date
- 1983-08-08
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- LDO
- Device class
- 2
- Regulation number
- 862.3900
- 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 |
|---|---|---|
| VITROS CHEMISTRY PRODUCTS TOBRA REAGENT, CALIBRATOR KIT 14 AND TDM PERFORMANCE VERIFIERS I, II AND III (K043384) | Ortho-Clinical Diagnostics, Inc. | 2005-02-07 |
| HEART - AID ALS, 95 (K841556) | Cardiac Resucitator Corp. | 1984-07-19 |
Recalls involving this device
No recalls on record reference this clearance.