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510(k) K864548

ALFERR TIBC TUBE by Benchmark Reagents — Product Code JQE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 1987
Date Received
November 19, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Resin, Ion-Exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity
Device Class
Class I
Regulation Number
862.1415
Review Panel
CH
Submission Type

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  • K910672 — J&S PEDIATRIC IRON SATURATING REAGENT (April 29, 1991)
  • K884649 — TOTAL IRON BINDING CAPACITY TEST (December 14, 1988)
  • K842019 — TIBC PRETREATMENT KIT (June 22, 1984)