510(k) K781337
K781337 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "CONJUGATED BILE ACIDS RIA KIT". The FDA issued a decision of Substantially Equivalent on August 11, 1978. The device falls under product code KWW (Radioimmunoassay, Cholyglycine, Bile Acids), a Class II device regulated under 21 CFR 862.1177. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 11, 1978
- Date Received
- August 3, 1978
- 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