510(k) K993941
K993941 is an FDA 510(k) premarket notification submitted by Marukin Diagnostics for the device "UBAS". The FDA issued a decision of Substantially Equivalent on March 2, 2000. The device falls under product code KWX (Radioimmunoassay, Conjugated Sulfalithocholic (Slcg) Acid, Bile Acids), a Class II device regulated under 21 CFR 862.1187.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 2, 2000
- Date Received
- November 19, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Conjugated Sulfalithocholic (Slcg) Acid, Bile Acids
- Device Class
- Class II
- Regulation Number
- 862.1187
- Review Panel
- CH
- Submission Type