510(k) K861646
K861646 is an FDA 510(k) premarket notification submitted by Societe D' Analyses Bio-Pharmaceutiques,Inc. for the device "BIO-CARB D16000, D16001, AND D17000". The FDA issued a decision of Substantially Equivalent on August 7, 1986. The device falls under product code FJH (Dialyzer, Disposable), a Class II device regulated under 21 CFR 876.5830.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 7, 1986
- Date Received
- April 30, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dialyzer, Disposable
- Device Class
- Class II
- Regulation Number
- 876.5830
- Review Panel
- GU
- Submission Type