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510(k) K843428

BIOFIX by Accra Laboratories, Inc. — Product Code LDZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1984
Date Received
September 4, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fixative, Alcohol Containing
Device Class
Class I
Regulation Number
864.4010
Review Panel
PA
Submission Type

Other clearances by Accra Laboratories, Inc.

  • K851494 — TWO-STEP ACID FAST BACTERIA STAIN (April 29, 1985)
  • K851493 — KINYOUN ACID FAST STAIN KIT (April 29, 1985)
  • K843425 — HARRIS HEMATOXYLIN, MERCURY FREE, ACID (October 2, 1984)
  • K843427 — GILL PAPANICOLAOU STAIN EA-1 & 2 OG-6 (October 2, 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 LDZ

  • K883048 — ATS PARA-SET MODIFIED PVA FIXATIVE SOLUTION (August 17, 1988)
  • K881922 — CYTOJARS PREFILLED WITH CYTOLOGY PRESERVATIVE (May 25, 1988)
  • K881698 — ATS PVA FIXATIVE SOLUTION (May 13, 1988)
  • K862725 — SACCOMANNO SPECIMAN SOLUTION (August 1, 1986)
  • K842913 — WRIGHT STAIN FIXATIVE (September 7, 1984)
  • K831061 — PVA FIXATIVE/FORMALIN (June 8, 1983)
  • K761138 — FA TISSUE FIXATIVE & WASH SET (January 6, 1978)