EMIT URINE METHADONE ASSAY #3E319
FDA 510(k) clearance K820900 · decided 1982-04-26
Clearance details
- K-number
- K820900
- Device name
- EMIT URINE METHADONE ASSAY #3E319
- Applicant
- Syva Co.
- Decision
- Substantially Equivalent
- Date received
- 1982-03-31
- Decision date
- 1982-04-26
- Days to decision
- 26 days
- Clearance type
- Traditional
- Product code
- DDE
- Device class
- 1
- Regulation number
- 866.5200
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- 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 |
|---|---|---|
| TENONE(TM) OPIATES CATALOG: VKSO1,4 (K902055) | Diagnostic Products Corp. | 1990-07-10 |
| COAT-A-COUNT MORPHINE KIT & COMPONENTS (K823680) | Diagnostic Products Corp. | 1983-01-05 |
Recalls involving this device
No recalls on record reference this clearance.