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510(k) K821320

HEMATOXYLIN STAIN by Sigma Chemical Co. — Product Code HYJ

K821320 is an FDA 510(k) premarket notification submitted by Sigma Chemical Co. for the device "HEMATOXYLIN STAIN". The FDA issued a decision of Substantially Equivalent on June 2, 1982. The device falls under product code HYJ (Hematoxylin), a Class I device regulated under 21 CFR 864.1850. Sigma Chemical Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 1982
Date Received
May 4, 1982
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 Sigma Chemical Co.

  • K933694 — SIGMA GLUCOSE REAGENT (November 4, 1994)
  • K933678 — SIGMA CALCIUM REAGENT (March 11, 1994)
  • K933696 — SIGMA ELECTROLYTE REFERENCE REAGENT (January 3, 1994)
  • K933691 — SIGMA CO2 ALKALINE BUFFER REAGENT (December 17, 1993)
  • K933679 — SIGMA BUN REAGENT (December 17, 1993)
  • K933703 — SIGMA WASH CONCENTRATE SOLUTION (December 10, 1993)
  • K933692 — SIGMA CO2 ACID REAGENT (December 9, 1993)
  • K933695 — SIGMA ELECTROLYTE BUFFER (October 22, 1993)
  • K933697 — SIGMA CRE REAGENT (October 18, 1993)
  • K933693 — SIGMA CX-3 CALIBRATION STANDARD LEVEL 2 (October 13, 1993)

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)
  • K842741 — GILL HEMATOXYLIN STAIN (August 15, 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)
  • K821062 — HEMATOXYLIN SOLUTION (April 29, 1982)

FDA data resources