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510(k) K812086

EA 65 by Surgipath — Product Code HZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 1981
Date Received
July 22, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stain, Papanicolau
Device Class
Class I
Regulation Number
864.1850
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)
  • 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)
  • K810760 — GILL'S HEMATOXYLIN #3 (April 14, 1981)
  • K810759 — GILL'S HEMATOXYLIN #2 (April 14, 1981)
  • K810733 — HARRIS HEMATOXYLIN (April 14, 1981)
  • K810758 — GILL'S HEMATOXYLIN #1 (April 14, 1981)

Other clearances for product code HZJ

  • K843427 — GILL PAPANICOLAOU STAIN EA-1 & 2 OG-6 (October 2, 1984)
  • K842739 — PAP STAIN, EA-36 (September 11, 1984)
  • K842735 — PAP STAIN EA-65 (September 11, 1984)
  • K842736 — PAP STAIN, OG-6 (August 17, 1984)
  • K842738 — PAP STAIN EA-50 (August 17, 1984)
  • K840054 — PAPANICOLAOU STAIN SYS HT40 (February 17, 1984)
  • K822035 — VOLU-SOL GILLS EA (August 3, 1982)
  • K820027 — MODIFIED EA 50 (February 4, 1982)
  • K812087 — EA 50 (August 13, 1981)
  • K800325 — VOLU-SOL HISTO./CYTO. STAIN MOD. #EA65 (February 26, 1980)