RH VIEWBOX
FDA 510(k) clearance K792306 · decided 1979-12-04
Clearance details
- K-number
- K792306
- Device name
- RH VIEWBOX
- Applicant
- Tekpro
- Decision
- Substantially Equivalent
- Date received
- 1979-11-16
- Decision date
- 1979-12-04
- Days to decision
- 18 days
- Clearance type
- Traditional
- Product code
- KSY
- Device class
- 1
- Regulation number
- 864.9185
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- 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.