EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORS
FDA 510(k) clearance K962519 · decided 1996-09-04
Clearance details
- K-number
- K962519
- Device name
- EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORS
- Applicant
- Behring Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-06-27
- Decision date
- 1996-09-04
- Days to decision
- 69 days
- Clearance type
- Traditional
- Product code
- LCD
- Device class
- 2
- Regulation number
- 862.3450
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- San Jose, CA, 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.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OPUS(R) CEA TEST SYSTEM (P920021/S001) | Behring Diagnostics, Inc. | 1996-02-23 |