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510(k) K854190

CANTROL SPINAL FLUID CONTROL by Canyon Diagnostics, Inc. — Product Code DFI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 1985
Date Received
October 15, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Total Spinal-Fluid, Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.5860
Review Panel
IM
Submission Type

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  • K882488 — CANTROL HDL CHOLESTEROL PRECIPI. REAG. AND TUBES (August 15, 1988)
  • 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)
  • 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 DFI

  • K843122 — RESOLVE-CSF (November 30, 1984)
  • K840974 — SOMAS HUMAN SPINAL FLUID CONTROL (April 5, 1984)
  • K832821 — FIAX IGG TEST (October 14, 1983)