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510(k) K872500

ANATECH HEMATOXYLIN-EXTRA STRENGTH by Anatech, Ltd. — Product Code HYJ

K872500 is an FDA 510(k) premarket notification submitted by Anatech, Ltd. for the device "ANATECH HEMATOXYLIN-EXTRA STRENGTH". The FDA issued a decision of Substantially Equivalent on July 9, 1987. The device falls under product code HYJ (Hematoxylin), a Class I device regulated under 21 CFR 864.1850. Anatech, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 1987
Date Received
June 24, 1987
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 Anatech, Ltd.

  • K882874 — ZINC FORMALIN (July 28, 1988)
  • K882873 — FIELDTEX HEMATOXYLIN (July 28, 1988)
  • K882268 — ZINC FORMALIN CONCENTRATE (June 15, 1988)
  • K881282 — XYLENE (April 5, 1988)
  • K872663 — DRY-FORM (August 6, 1987)
  • K872498 — HARRIS HEMATOXYLIN (July 9, 1987)
  • K872499 — ANATECH HEMATOXYLIN-NORMAL STRENGTH (July 9, 1987)
  • K870852 — NBF 10% NEUTRAL BUFFERED FORMALIN (March 31, 1987)
  • K842862 — CB FORMALIN (August 28, 1984)
  • K842940 — CBA FORMALIN (August 28, 1984)

Other clearances for product code HYJ

  • K872499 — ANATECH HEMATOXYLIN-NORMAL 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)
  • K821320 — HEMATOXYLIN STAIN (June 2, 1982)
  • K821062 — HEMATOXYLIN SOLUTION (April 29, 1982)

FDA data resources