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510(k) K842741

GILL HEMATOXYLIN STAIN by E K Ind., Inc. — Product Code HYJ

K842741 is an FDA 510(k) premarket notification submitted by E K Ind., Inc. for the device "GILL HEMATOXYLIN STAIN". The FDA issued a decision of Substantially Equivalent on August 15, 1984. The device falls under product code HYJ (Hematoxylin), 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 15, 1984
Date Received
July 13, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hematoxylin
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 HYJ

  • K872499 — ANATECH HEMATOXYLIN-NORMAL STRENGTH (July 9, 1987)
  • K872500 — ANATECH HEMATOXYLIN-EXTRA STRENGTH (July 9, 1987)
  • K842740 — DELAFIELD HEMATOXYLIN STAIN (August 17, 1984)
  • K831090 — HEMATOXYLIN GILL FORMULATION IX#56016 (June 8, 1983)
  • K822352 — HEMATOXYLIN STAIN SOLUTION (August 16, 1982)
  • K821540 — HEMATOXYLIN II (June 10, 1982)
  • K821533 — HEMATOXYLIN I (June 10, 1982)
  • K821541 — HEMATOXYLIN III (June 10, 1982)
  • K821320 — HEMATOXYLIN STAIN (June 2, 1982)
  • K821062 — HEMATOXYLIN SOLUTION (April 29, 1982)

FDA data resources