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510(k) K842745

WRIGHT-GIEMSA QUICK STAIN by E K Ind., Inc. — Product Code IAF

K842745 is an FDA 510(k) premarket notification submitted by E K Ind., Inc. for the device "WRIGHT-GIEMSA QUICK STAIN". The FDA issued a decision of Substantially Equivalent on August 10, 1984. The device falls under product code IAF (Wright'S Stain), a Class I device regulated under 21 CFR 864.1850. E K Ind., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 1984
Date Received
July 13, 1984
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

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)
  • K842927 — LIGHT GREEN SF 1% (September 11, 1984)
  • K842731 — FORMALIN-ACETO-ALCOHOL FIXATIVE (September 11, 1984)
  • K842918 — SCOTTS TAP WATER SUBSTITUTE (September 11, 1984)
  • K842930 — GOMORI'S TRICHROME STAIN (September 11, 1984)

Other clearances for product code IAF

  • K890674 — ACCUSTAIN(TM) - AUTOMATED WRIGHT GIEMSA STAIN SET (February 24, 1989)
  • K890673 — WRIGHT-GLEMSA STAIN (February 24, 1989)
  • 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)
  • K833678 — HEMATOLOGY WRIGHT'S STAIN PACK (November 25, 1983)
  • K833260 — STAIN PACK FOR AEROSPRAY SLIDE STAINER (October 28, 1983)
  • K831605 — HEMATOLOGY PAK (June 30, 1983)

FDA data resources