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510(k) K811802

HEMATOXYLIN by Richard-Allan Medical Ind., Inc. — Product Code HYJ

K811802 is an FDA 510(k) premarket notification submitted by Richard-Allan Medical Ind., Inc. for the device "HEMATOXYLIN". The FDA issued a decision of Substantially Equivalent on July 28, 1981. The device falls under product code HYJ (Hematoxylin), a Class I device regulated under 21 CFR 864.1850. Richard-Allan Medical Ind., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1981
Date Received
June 24, 1981
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 Richard-Allan Medical Ind., Inc.

  • K931879 — REFLEX HTR (March 24, 1994)
  • K924200 — REFLEX(R) ESC (February 22, 1994)
  • K926297 — REFLEX ESI (October 15, 1993)
  • K924761 — STERILE ENDOSCOPIC DISPOS TROCARS W/SAFE SHIELD (April 20, 1993)
  • K900566 — RICHARD-ALLAN VESSEL LOOPS (May 3, 1990)
  • K896262 — TITANIUM LIGATING CLIPS (January 2, 1990)
  • K890314 — PROTECTOR (SURGICAL INSTRUMENT) (February 27, 1989)
  • K873309 — REFLEX(TM) CA-T CLIP APPLIER (November 27, 1987)
  • K862404 — REFLEX(TM) CLIP APPLIER (July 23, 1986)
  • K862223 — MICRO THIN* PARAFFIN (June 17, 1986)

Other clearances for product code HYJ

  • K872500 — ANATECH HEMATOXYLIN-EXTRA STRENGTH (July 9, 1987)
  • 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)
  • K821533 — HEMATOXYLIN I (June 10, 1982)
  • K821540 — HEMATOXYLIN II (June 10, 1982)
  • K821541 — HEMATOXYLIN III (June 10, 1982)
  • K821320 — HEMATOXYLIN STAIN (June 2, 1982)

FDA data resources