510(k) K810144
K810144 is an FDA 510(k) premarket notification submitted by Bioware Products for the device "ALK-PHOS BIOPAK GEL". The FDA issued a decision of Substantially Equivalent on February 2, 1981. The device falls under product code CIN (Electrophoretic Separation, Alkaline Phosphatase Isoenzymes), a Class II device regulated under 21 CFR 862.1050. Bioware Products has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 2, 1981
- Date Received
- January 21, 1981
- 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