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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device radioimmunoassay, immunoglobulins (d, e)
Regulation Description Immunoglobulins A, G, M, D, and E immunological test system.
Product CodeJHR
Regulation Number 866.5510
Device Class 2


Premarket Reviews
ManufacturerDecision
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 1
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 3
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1

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