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510(k) K843427

GILL PAPANICOLAOU STAIN EA-1 & 2 OG-6 by Accra Laboratories, Inc. — Product Code HZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 1984
Date Received
September 4, 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

Other clearances by Accra Laboratories, Inc.

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  • K843425 — HARRIS HEMATOXYLIN, MERCURY FREE, ACID (October 2, 1984)
  • K843426 — EOSIN Y 1% ALCOHOLIC (September 27, 1984)
  • K843428 — BIOFIX (September 27, 1984)
  • K843429 — GRAM STAIN SET W/STABILIZED IODINE (September 14, 1984)
  • K831090 — HEMATOXYLIN GILL FORMULATION IX#56016 (June 8, 1983)
  • K830542 — HEMAQUIK II STAINING SOLUTION #55961 (March 17, 1983)
  • K823329 — PAPINCOLABU STAIN EA-36/50/65 & OG-6 (December 28, 1982)
  • K823328 — HARRIS HEMATOXYLIN (December 28, 1982)

Other clearances for product code HZJ

  • 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)
  • K812086 — EA 65 (August 13, 1981)
  • K800325 — VOLU-SOL HISTO./CYTO. STAIN MOD. #EA65 (February 26, 1980)