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510(k) K823445

ALKPHOR SYSTEM by California Immuno Diagnostic, Inc. — Product Code CIN

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

Other clearances by California Immuno Diagnostic, Inc.

  • K831623 — DIA STRIPS SYSTEM (July 28, 1983)
  • K800698 — AUTOFLUOR SYSTEM (May 28, 1980)

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