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510(k) K891604

THE CEN-SLIDE(TM) CENTRIFUGE TUBE by Davstar California, Inc. — Product Code KEW

K891604 is an FDA 510(k) premarket notification submitted by Davstar California, Inc. for the device "THE CEN-SLIDE(TM) CENTRIFUGE TUBE". The FDA issued a decision of Substantially Equivalent on June 16, 1989. The device falls under product code KEW (Slides, Microscope), a Class I device regulated under 21 CFR 864.3010.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1989
Date Received
March 20, 1989
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 for product code KEW

  • 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)
  • K800232 — ABCO ULTRA SLIDE MICROSCOPE SLIDE (February 21, 1980)
  • K760278 — SLIDE, LAB-TEK COVERED MICRO (August 30, 1976)

FDA data resources