510(k) K872296
K872296 is an FDA 510(k) premarket notification submitted by Sigma Diagnostics, Inc. for the device "BILE ACIDS REAGENT". The FDA issued a decision of Substantially Equivalent on August 26, 1987. The device falls under product code KWW (Radioimmunoassay, Cholyglycine, Bile Acids), a Class II device regulated under 21 CFR 862.1177. Sigma Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 26, 1987
- Date Received
- June 16, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Cholyglycine, Bile Acids
- Device Class
- Class II
- Regulation Number
- 862.1177
- Review Panel
- CH
- Submission Type