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510(k) K831065

SECTIONING AID KIT by Technicon Instruments Corp. — Product Code KEW

K831065 is an FDA 510(k) premarket notification submitted by Technicon Instruments Corp. for the device "SECTIONING AID KIT". The FDA issued a decision of Substantially Equivalent on June 8, 1983. The device falls under product code KEW (Slides, Microscope), a Class I device regulated under 21 CFR 864.3010. Technicon Instruments Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 1983
Date Received
April 4, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Slides, Microscope
Device Class
Class I
Regulation Number
864.3010
Review Panel
PA
Submission Type

Other clearances by Technicon Instruments Corp.

  • K914888 — TECHNICON CHEM 1(TM) SYST (GEN2 SYST) (November 27, 1991)
  • K914511 — TECHNICON AXON(TM) SYSTEM METHODS ANYALYE HDL CHOL (November 27, 1991)
  • K914025 — TECHNICON AXON(TM) SYSTEMS, ALT(P 5-P)/AST(P 5-P) (November 22, 1991)
  • K912616 — TECHNICON IMMUNO 1 TM SYSTEM ADDITIONAL ANALYTES (September 25, 1991)
  • K912413 — CHEM-LINK DATA BASE MANAGER (July 1, 1991)
  • K903305 — TECHNICON CHEM I SYSTEM CARBON DIOXIDE METHOD (September 27, 1990)
  • K903825 — DRUG OF ABUSE ANALYSIS SYSTEM (September 27, 1990)
  • K903824 — DRUG OF ABUSE ANALYSIS SYSTEM FREE RADICAL ASSAY (September 27, 1990)
  • K903306 — TECHNICON CHEM I SYSTEM MAGNESIUM METHOD (August 29, 1990)
  • K901410 — TECHNICON RA-2000(TM) SYSTEM (July 17, 1990)

Other clearances for product code KEW

  • K891604 — THE CEN-SLIDE(TM) CENTRIFUGE TUBE (June 16, 1989)
  • K890042 — MICROSCOPE SLIDES PRECOATED (January 13, 1989)
  • K882357 — MICROSCOPE SLIDES PRECOATED W/HISTOGRIP & POLY-LY (June 16, 1988)
  • K820100 — FROSTED GLASS SLIDES (March 4, 1982)
  • K813242 — QUANTIMETRIC 2 TEST KIT (December 2, 1981)
  • K800232 — ABCO ULTRA SLIDE MICROSCOPE SLIDE (February 21, 1980)
  • K760278 — SLIDE, LAB-TEK COVERED MICRO (August 30, 1976)

FDA data resources