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510(k) K864548

ALFERR TIBC TUBE by Benchmark Reagents — Product Code JQE

K864548 is an FDA 510(k) premarket notification submitted by Benchmark Reagents for the device "ALFERR TIBC TUBE". The FDA issued a decision of Substantially Equivalent on February 2, 1987. The device falls under product code JQE (Resin, Ion-Exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity), a Class I device regulated under 21 CFR 862.1415.

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

Other clearances for product code JQE

  • K970248 — CANTROL SERUM IRON AND TOTAL IRON BINDING CAPACITY TEST SYSTEM (February 11, 1997)
  • K934358 — KODAK EKTACHEM DT SLIDES (FE) (March 21, 1994)
  • 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)

FDA data resources