510(k) K832749
K832749 is an FDA 510(k) premarket notification submitted by Worthington Diagnostic Systems for the device "EASYTOUCH BUN REAGENT SET". The FDA issued a decision of Substantially Equivalent on October 14, 1983. The device falls under product code CDQ (Urease And Glutamic Dehydrogenase, Urea Nitrogen), a Class II device regulated under 21 CFR 862.1770. Worthington Diagnostic Systems has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 14, 1983
- Date Received
- August 15, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Urease And Glutamic Dehydrogenase, Urea Nitrogen
- Device Class
- Class II
- Regulation Number
- 862.1770
- Review Panel
- CH
- Submission Type