510(k) K885094
K885094 is an FDA 510(k) premarket notification submitted by Biotrol, USA, Inc. for the device "BIOTROL ALBUMIN". The FDA issued a decision of Substantially Equivalent on February 10, 1989. The device falls under product code CIX (Bromcresol Green Dye-Binding, Albumin), a Class II device regulated under 21 CFR 862.1035. Biotrol, USA, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 10, 1989
- Date Received
- December 9, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bromcresol Green Dye-Binding, Albumin
- Device Class
- Class II
- Regulation Number
- 862.1035
- Review Panel
- CH
- Submission Type