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510(k) K843425

HARRIS HEMATOXYLIN, MERCURY FREE, ACID by Accra Laboratories, Inc. — Product Code HYK

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
Hematoxylin Harris'S
Device Class
Class I
Regulation Number
864.1850
Review Panel
PA
Submission Type

Other clearances by Accra Laboratories, Inc.

  • K851493 — KINYOUN ACID FAST STAIN KIT (April 29, 1985)
  • K851494 — TWO-STEP ACID FAST BACTERIA STAIN (April 29, 1985)
  • 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)
  • 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 HYK

  • K873107 — INSTANT HEMATOXYLIN (August 21, 1987)
  • K872498 — HARRIS HEMATOXYLIN (July 9, 1987)
  • K823328 — HARRIS HEMATOXYLIN (December 28, 1982)
  • K810733 — HARRIS HEMATOXYLIN (April 14, 1981)
  • K800324 — VOLU-SOL HARRIS HEMATOXYLIN (February 22, 1980)
  • K781585 — HEMATOXYLIN STAIN HARRIS (October 10, 1978)