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510(k) K910672

J&S PEDIATRIC IRON SATURATING REAGENT by J.S. Medical Assoc. — Product Code JQE

K910672 is an FDA 510(k) premarket notification submitted by J.S. Medical Assoc. for the device "J&S PEDIATRIC IRON SATURATING REAGENT". The FDA issued a decision of Substantially Equivalent on April 29, 1991. 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. J.S. Medical Assoc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 1991
Date Received
February 15, 1991
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 by J.S. Medical Assoc.

  • K932752 — VISI-SPOT (November 5, 1993)
  • K932688 — EYE SPOT IM TEST (September 8, 1993)
  • K932180 — EYE SPOT CRP TEST (August 23, 1993)
  • K932551 — ACCUTEX IM LATEX TEST (August 9, 1993)
  • K926112 — ACCUTEX BETA-HCG TEST (July 28, 1993)
  • K924332 — ACCUTEX CRP LATEX TEST (December 7, 1992)
  • K924247 — ACCUTEX ASO LATEX TEST (December 7, 1992)
  • K924036 — ACCUTEX RHEUMATIOD FACTOR (RF) LATEX TEST (December 1, 1992)
  • K924037 — ACCUTEX IM RBC TEST (November 2, 1992)
  • K924248 — ACCUTEX SLE LATEX TEST (November 2, 1992)

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)
  • K884649 — TOTAL IRON BINDING CAPACITY TEST (December 14, 1988)
  • K864548 — ALFERR TIBC TUBE (February 2, 1987)
  • K842019 — TIBC PRETREATMENT KIT (June 22, 1984)

FDA data resources