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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device electrophoretic separation, alkaline phosphatase isoenzymes
Product CodeCIN
Regulation Number 862.1050
Device Class 2


Premarket Reviews
ManufacturerDecision
IMMUNODIAGNOSTIC SYSTEMS LTD.
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Mar-21-2012
2 Beckman Coulter Inc. II Mar-09-2012
3 Diagnostic Hybrids, Inc. II May-10-2018
4 Immunodiagnostics Systems Ltd II Oct-10-2012
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