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510(k) K881477

HISTOGRIP & HISTOGRIP GOLD CONCENTRATE/PREDILUTED by Stat Path — Product Code KEL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 1988
Date Received
April 7, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Adhesive, Albumin-Based
Device Class
Class I
Regulation Number
864.4010
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)
  • K882357 — MICROSCOPE SLIDES PRECOATED W/HISTOGRIP & POLY-LY (June 16, 1988)

Other clearances for product code KEL

  • K890022 — ATS MAYER'S ALBUMIN (January 10, 1989)