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510(k) K842742

GIEMSA STAIN by E K Ind., Inc. — Product Code HYF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 1984
Date Received
July 13, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Giemsa Stain
Device Class
Class I
Regulation Number
864.1850
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)
  • K842935 — ACETIC ACID, 5% V/V (September 12, 1984)
  • K842937 — ACETIC ACID 2% V/V (September 12, 1984)
  • K842923 — PICRIC ACID 1% W/V (September 11, 1984)
  • K842918 — SCOTTS TAP WATER SUBSTITUTE (September 11, 1984)
  • K842916 — SUDAN IV HERXHEIMER (September 11, 1984)
  • K842930 — GOMORI'S TRICHROME STAIN (September 11, 1984)

Other clearances for product code HYF

  • K833665 — HEMATOLOGY WRIGHT'S-GIEMSA SATIN PACK (November 25, 1983)
  • K833677 — QUICK STAIN WRIGHT'S GIEMSA W/BUFF (November 25, 1983)
  • K831131 — CASE WRIGHT-GIEMSA STAIN PAK (June 8, 1983)