EMIT AED ASSAYS 3500 COMPUTER DIRECTED
FDA 510(k) clearance K790255 · decided 1979-03-02
Clearance details
- K-number
- K790255
- Device name
- EMIT AED ASSAYS 3500 COMPUTER DIRECTED
- Applicant
- Syva Co.
- Decision
- Substantially Equivalent
- Date received
- 1979-02-06
- Decision date
- 1979-03-02
- Days to decision
- 24 days
- Clearance type
- Traditional
- Product code
- KLT
- Device class
- 2
- Regulation number
- 862.3645
- 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.