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510(k) K894416

RAICHEM(TM) SPIA(TM) IGG REAGENTS by Reagents Applications, Inc. — Product Code KTO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 1989
Date Received
July 17, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reagent, Immunoassay, Igg
Device Class
Class I
Regulation Number
866.5530
Review Panel
IM
Submission Type

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Other clearances for product code KTO

  • K854483 — KALLESTAD QUANTIMETRIC PLUS IGG REAGENT KIT (December 11, 1985)