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510(k) K842913

WRIGHT STAIN FIXATIVE by E K Ind., Inc. — Product Code LDZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 1984
Date Received
July 25, 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 E K Ind., Inc.

  • K842931 — DRABKIN REAGENT (September 21, 1984)
  • K842938 — ACETIC ACID 1% V/V (September 14, 1984)
  • K842934 — DECOLORIZING FLUIC, ACID-ALCOHOL 3% (September 12, 1984)
  • K842936 — ACETIC ACID, 3% V/V (September 12, 1984)
  • K842937 — ACETIC ACID 2% V/V (September 12, 1984)
  • K842935 — ACETIC ACID, 5% V/V (September 12, 1984)
  • K842928 — JENNER BLOOD STAIN (September 11, 1984)
  • K842739 — PAP STAIN, EA-36 (September 11, 1984)
  • K842925 — MUCI-CARMINE STAIN, MAYER'S FORMULA (September 11, 1984)
  • K842927 — LIGHT GREEN SF 1% (September 11, 1984)

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)
  • K843428 — BIOFIX (September 27, 1984)
  • K831061 — PVA FIXATIVE/FORMALIN (June 8, 1983)
  • K761138 — FA TISSUE FIXATIVE & WASH SET (January 6, 1978)