510(k) K792306
K792306 is an FDA 510(k) premarket notification submitted by Tekpro for the device "RH VIEWBOX". The FDA issued a decision of Substantially Equivalent on December 4, 1979. The device falls under product code KSY (Boxes, View, Blood Grouping), a Class I device regulated under 21 CFR 864.9185. Tekpro has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 4, 1979
- Date Received
- November 16, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Boxes, View, Blood Grouping
- Device Class
- Class I
- Regulation Number
- 864.9185
- Review Panel
- HE
- Submission Type