510(k) K963537
K963537 is an FDA 510(k) premarket notification submitted by Sigma Diagnostics, Inc. for the device "SIGMA DIAGNOSTICS BUN REAGENT". The FDA issued a decision of Substantially Equivalent on October 24, 1996. The device falls under product code LFP (Conductivity Rate, Urea Nitrogen), a Class II device regulated under 21 CFR 862.1770. Sigma Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 24, 1996
- Date Received
- September 4, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Conductivity Rate, Urea Nitrogen
- Device Class
- Class II
- Regulation Number
- 862.1770
- Review Panel
- CH
- Submission Type