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510(k) K830542

HEMAQUIK II STAINING SOLUTION #55961 by Accra Laboratories, Inc. — Product Code IAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 1983
Date Received
February 22, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wright'S Stain
Device Class
Class I
Regulation Number
864.1850
Review Panel
PA
Submission Type

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  • K843427 — GILL PAPANICOLAOU STAIN EA-1 & 2 OG-6 (October 2, 1984)
  • K843428 — BIOFIX (September 27, 1984)
  • K843426 — EOSIN Y 1% ALCOHOLIC (September 27, 1984)
  • K843429 — GRAM STAIN SET W/STABILIZED IODINE (September 14, 1984)
  • K831090 — HEMATOXYLIN GILL FORMULATION IX#56016 (June 8, 1983)
  • K823329 — PAPINCOLABU STAIN EA-36/50/65 & OG-6 (December 28, 1982)
  • K823328 — HARRIS HEMATOXYLIN (December 28, 1982)

Other clearances for product code IAF

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  • K854236 — HISTAMINE RIA TEST FOR HISTAMINE BIOLOGICAL FLUIDS (October 10, 1986)
  • K860793 — CAMCO STAIN PAK (March 18, 1986)
  • K853241 — HEMATOLOGY STAIN PACK (August 19, 1985)
  • K852138 — WESCOR STAIN PACK FOR MODEL 7100 AEROSPRAY SLIDE S (June 13, 1985)
  • K842744 — WRIGHT STAIN (August 12, 1984)
  • K842745 — WRIGHT-GIEMSA QUICK STAIN (August 10, 1984)
  • K833678 — HEMATOLOGY WRIGHT'S STAIN PACK (November 25, 1983)
  • K833260 — STAIN PACK FOR AEROSPRAY SLIDE STAINER (October 28, 1983)