URINE NEGATIVE CALIBRATOR
FDA 510(k) clearance K790400 · decided 1979-06-15
Clearance details
- K-number
- K790400
- Device name
- URINE NEGATIVE CALIBRATOR
- Applicant
- Syva Co.
- Decision
- Substantially Equivalent
- Date received
- 1979-02-26
- Decision date
- 1979-06-15
- Days to decision
- 109 days
- Clearance type
- Traditional
- Product code
- DLT
- Device class
- 2
- Regulation number
- 862.3650
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.