510(k) K852131
K852131 is an FDA 510(k) premarket notification submitted by Sigma Diagnostics, Inc. for the device "BUN(ENDPOINT) REAGENT". The FDA issued a decision of Substantially Equivalent on Jun 10, 1985. The device falls under product code CDQ (Urease And Glutamic Dehydrogenase, Urea Nitrogen), a Class II device regulated under 21 CFR 862.1770. Sigma Diagnostics, Inc. has 163 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 10, 1985
- Date Received
- May 16, 1985
- 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
- 510(k)