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510(k) K840054

PAPANICOLAOU STAIN SYS HT40 by Sigma Chemical Co. — Product Code HZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 1984
Date Received
January 6, 1984
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

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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)
  • K822035 — VOLU-SOL GILLS EA (August 3, 1982)
  • K820027 — MODIFIED EA 50 (February 4, 1982)
  • K812087 — EA 50 (August 13, 1981)
  • K812086 — EA 65 (August 13, 1981)
  • K800325 — VOLU-SOL HISTO./CYTO. STAIN MOD. #EA65 (February 26, 1980)