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510(k) K970248

CANTROL SERUM IRON AND TOTAL IRON BINDING CAPACITY TEST SYSTEM by Canyon Diagnostics, Inc. — Product Code JQE

K970248 is an FDA 510(k) premarket notification submitted by Canyon Diagnostics, Inc. for the device "CANTROL SERUM IRON AND TOTAL IRON BINDING CAPACITY TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on February 11, 1997. 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. Canyon Diagnostics, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 1997
Date Received
January 22, 1997
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 Canyon Diagnostics, Inc.

  • K964640 — CANTROL IRON/TIBC CONTROLS, LEVEL 1 AND LEVEL 2 PRODUCT NUMBERS: LEVEL 1: IIBC-9 (December 13, 1996)
  • K882488 — CANTROL HDL CHOLESTEROL PRECIPI. REAG. AND TUBES (August 15, 1988)
  • K871537 — CANTROL HDL CHOLESTROL CONTROLS LEVELS I AND II (May 6, 1987)
  • K854931 — CANTROL ELECTROPHORESIS CONTROL (January 17, 1986)
  • K855006 — CANTROL CK/MB CONTROL (January 17, 1986)
  • K854190 — CANTROL SPINAL FLUID CONTROL (November 25, 1985)
  • K853603 — CANTROL URINE DIPSTICK CONTROL TWO LEVELS (October 8, 1985)
  • K852138 — WESCOR STAIN PACK FOR MODEL 7100 AEROSPRAY SLIDE S (June 13, 1985)

Other clearances for product code JQE

  • 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)
  • K864548 — ALFERR TIBC TUBE (February 2, 1987)
  • K842019 — TIBC PRETREATMENT KIT (June 22, 1984)

FDA data resources