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510(k) K800232

ABCO ULTRA SLIDE MICROSCOPE SLIDE by Abco Dealers, Inc. — Product Code KEW

K800232 is an FDA 510(k) premarket notification submitted by Abco Dealers, Inc. for the device "ABCO ULTRA SLIDE MICROSCOPE SLIDE". The FDA issued a decision of Substantially Equivalent on February 21, 1980. The device falls under product code KEW (Slides, Microscope), a Class I device regulated under 21 CFR 864.3010. Abco Dealers, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 1980
Date Received
February 5, 1980
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 Abco Dealers, Inc.

  • K905025 — DIGITAL THERMOMETER KITS (February 7, 1991)
  • K882304 — DIGITAL THERMOMETER SHEATHS (ORAL AND RECTAL) (July 12, 1988)
  • K880892 — BLOOD COLLECTING NEEDLE AND HOLDERS (April 21, 1988)
  • K880894 — ALLERGIST SYRINGES (March 31, 1988)
  • K872875 — STRETCH GAUZE BANDAGES (September 4, 1987)
  • K872874 — MICROSCOPE COVER GLASSES (August 10, 1987)
  • K872797 — NON-SKID SHOE COVERS (August 4, 1987)
  • K871465 — THERMOMETER SHEATHS (May 11, 1987)
  • K862726 — DISPOSABLE SHOE COVERS AND NURSES CAPS (August 1, 1986)
  • K862111 — ARMBOARDS, REUSABLE AND DISPOSABLE (July 8, 1986)

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)
  • K831065 — SECTIONING AID KIT (June 8, 1983)
  • K820100 — FROSTED GLASS SLIDES (March 4, 1982)
  • K813242 — QUANTIMETRIC 2 TEST KIT (December 2, 1981)
  • K760278 — SLIDE, LAB-TEK COVERED MICRO (August 30, 1976)

FDA data resources