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510(k) K964640

CANTROL IRON/TIBC CONTROLS, LEVEL 1 AND LEVEL 2 PRODUCT NUMBERS: LEVEL 1: IIBC-91 AND LEVEL 2: IIBC-92 by Canyon Diagnostics, Inc. — Product Code JJY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 1996
Date Received
November 19, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Multi-Analyte Controls, All Kinds (Assayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

Other clearances by Canyon Diagnostics, Inc.

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  • K871537 — CANTROL HDL CHOLESTROL CONTROLS LEVELS I AND II (May 6, 1987)
  • K855006 — CANTROL CK/MB CONTROL (January 17, 1986)
  • K854931 — CANTROL ELECTROPHORESIS 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)

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