510(k) K823445
K823445 is an FDA 510(k) premarket notification submitted by California Immuno Diagnostic, Inc. for the device "ALKPHOR SYSTEM". The FDA issued a decision of Substantially Equivalent on December 28, 1982. The device falls under product code CIN (Electrophoretic Separation, Alkaline Phosphatase Isoenzymes), a Class II device regulated under 21 CFR 862.1050. California Immuno Diagnostic, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 28, 1982
- Date Received
- November 16, 1982
- 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