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510(k) K882357

MICROSCOPE SLIDES PRECOATED W/HISTOGRIP & POLY-LY by Stat Path — Product Code KEW

K882357 is an FDA 510(k) premarket notification submitted by Stat Path for the device "MICROSCOPE SLIDES PRECOATED W/HISTOGRIP & POLY-LY". The FDA issued a decision of Substantially Equivalent on June 16, 1988. The device falls under product code KEW (Slides, Microscope), a Class I device regulated under 21 CFR 864.3010. Stat Path has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1988
Date Received
June 7, 1988
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 Stat Path

  • K890042 — MICROSCOPE SLIDES PRECOATED (January 13, 1989)
  • K882362 — STAT FIX MICROWAVE IRRADIATION MEDIUM (June 22, 1988)
  • K881477 — HISTOGRIP & HISTOGRIP GOLD CONCENTRATE/PREDILUTED (April 18, 1988)

Other clearances for product code KEW

  • K891604 — THE CEN-SLIDE(TM) CENTRIFUGE TUBE (June 16, 1989)
  • K890042 — MICROSCOPE SLIDES PRECOATED (January 13, 1989)
  • 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