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510(k) K810323

ACRYTOL, MOUNTING MEDIUM by Surgipath — Product Code KEP

K810323 is an FDA 510(k) premarket notification submitted by Surgipath for the device "ACRYTOL, MOUNTING MEDIUM". The FDA issued a decision of Substantially Equivalent on March 6, 1981. The device falls under product code KEP (Media, Mounting, Oil Soluble), a Class I device regulated under 21 CFR 864.4010. Surgipath has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 1981
Date Received
February 6, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Mounting, Oil Soluble
Device Class
Class I
Regulation Number
864.4010
Review Panel
PA
Submission Type

Other clearances by Surgipath

  • K820027 — MODIFIED EA 50 (February 4, 1982)
  • K812940 — 10% NEUTRAL BUFFERED FORMALIN CONCENT (December 10, 1981)
  • K812086 — EA 65 (August 13, 1981)
  • K812087 — EA 50 (August 13, 1981)
  • K811826 — EOSIN Y (July 10, 1981)
  • K811825 — ORANGE G-6 (July 10, 1981)
  • K810836 — DECALCIFIER II (April 23, 1981)
  • K810758 — GILL'S HEMATOXYLIN #1 (April 14, 1981)
  • K810759 — GILL'S HEMATOXYLIN #2 (April 14, 1981)
  • K810733 — HARRIS HEMATOXYLIN (April 14, 1981)

Other clearances for product code KEP

  • K830659 — CLEARIUM, MOUNTING MEDIUM (March 17, 1983)
  • K800847 — ENTELLAN (May 8, 1980)

FDA data resources