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510(k) K894418

RAICHEM(TM) SPIA(TM) IGA REAGENTS by Reagents Applications, Inc. — Product Code CZP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 1989
Date Received
July 17, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Iga, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
Submission Type

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  • K905084 — RAICHEM CREATINE KINASE REAGENT, OPTIMIZED UV (December 20, 1990)
  • K905085 — RAICHEM GGT REAGENT (December 20, 1990)

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