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510(k) K820027

MODIFIED EA 50 by Surgipath — Product Code HZJ

K820027 is an FDA 510(k) premarket notification submitted by Surgipath for the device "MODIFIED EA 50". The FDA issued a decision of Substantially Equivalent on February 4, 1982. The device falls under product code HZJ (Stain, Papanicolau), a Class I device regulated under 21 CFR 864.1850. Surgipath has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1982
Date Received
January 5, 1982
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

  • 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)
  • K810760 — GILL'S HEMATOXYLIN #3 (April 14, 1981)
  • K810759 — GILL'S HEMATOXYLIN #2 (April 14, 1981)
  • K810733 — HARRIS HEMATOXYLIN (April 14, 1981)

Other clearances for product code HZJ

  • K843427 — GILL PAPANICOLAOU STAIN EA-1 & 2 OG-6 (October 2, 1984)
  • K842735 — PAP STAIN EA-65 (September 11, 1984)
  • K842739 — PAP STAIN, EA-36 (September 11, 1984)
  • K842738 — PAP STAIN EA-50 (August 17, 1984)
  • K842736 — PAP STAIN, OG-6 (August 17, 1984)
  • K840054 — PAPANICOLAOU STAIN SYS HT40 (February 17, 1984)
  • K822035 — VOLU-SOL GILLS EA (August 3, 1982)
  • K812087 — EA 50 (August 13, 1981)
  • K812086 — EA 65 (August 13, 1981)
  • K800325 — VOLU-SOL HISTO./CYTO. STAIN MOD. #EA65 (February 26, 1980)

FDA data resources