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510(k) K852138

WESCOR STAIN PACK FOR MODEL 7100 AEROSPRAY SLIDE S by Canyon Diagnostics, Inc. — Product Code IAF

K852138 is an FDA 510(k) premarket notification submitted by Canyon Diagnostics, Inc. for the device "WESCOR STAIN PACK FOR MODEL 7100 AEROSPRAY SLIDE S". The FDA issued a decision of Substantially Equivalent on June 13, 1985. The device falls under product code IAF (Wright'S Stain), a Class I device regulated under 21 CFR 864.1850. Canyon Diagnostics, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 1985
Date Received
May 16, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wright'S Stain
Device Class
Class I
Regulation Number
864.1850
Review Panel
PA
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)
  • K854190 — CANTROL SPINAL FLUID CONTROL (November 25, 1985)
  • K853603 — CANTROL URINE DIPSTICK CONTROL TWO LEVELS (October 8, 1985)

Other clearances for product code IAF

  • K890673 — WRIGHT-GLEMSA STAIN (February 24, 1989)
  • K890674 — ACCUSTAIN(TM) - AUTOMATED WRIGHT GIEMSA STAIN SET (February 24, 1989)
  • K854236 — HISTAMINE RIA TEST FOR HISTAMINE BIOLOGICAL FLUIDS (October 10, 1986)
  • K860793 — CAMCO STAIN PAK (March 18, 1986)
  • K853241 — HEMATOLOGY STAIN PACK (August 19, 1985)
  • K842744 — WRIGHT STAIN (August 12, 1984)
  • K842745 — WRIGHT-GIEMSA QUICK STAIN (August 10, 1984)
  • K833678 — HEMATOLOGY WRIGHT'S STAIN PACK (November 25, 1983)
  • K833260 — STAIN PACK FOR AEROSPRAY SLIDE STAINER (October 28, 1983)
  • K831605 — HEMATOLOGY PAK (June 30, 1983)

FDA data resources