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510(k) K854190

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

K854190 is an FDA 510(k) premarket notification submitted by Canyon Diagnostics, Inc. for the device "CANTROL SPINAL FLUID CONTROL". The FDA issued a decision of Substantially Equivalent on November 25, 1985. The device falls under product code DFI (Total Spinal-Fluid, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5860. Canyon Diagnostics, Inc. has at least 8 other 510(k) clearances on record.

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

Other clearances by Canyon Diagnostics, Inc.

  • K970248 — CANTROL SERUM IRON AND TOTAL IRON BINDING CAPACITY TEST SYSTEM (February 11, 1997)
  • 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)
  • 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)

FDA data resources