510(k) K885024
K885024 is an FDA 510(k) premarket notification submitted by Ciba Corning Diagnostics Corp. for the device "ALKALINE PHOSPHATASE ISOENZYME SYSTEM". The FDA issued a decision of Substantially Equivalent on February 17, 1989. The device falls under product code CIN (Electrophoretic Separation, Alkaline Phosphatase Isoenzymes), a Class II device regulated under 21 CFR 862.1050. Ciba Corning Diagnostics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 17, 1989
- Date Received
- December 5, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
- Device Class
- Class II
- Regulation Number
- 862.1050
- Review Panel
- CH
- Submission Type