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510(k) K882873

FIELDTEX HEMATOXYLIN by Anatech, Ltd. — Product Code KQC

K882873 is an FDA 510(k) premarket notification submitted by Anatech, Ltd. for the device "FIELDTEX HEMATOXYLIN". The FDA issued a decision of Substantially Equivalent on July 28, 1988. The device falls under product code KQC (Stains, Hematology), 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 28, 1988
Date Received
July 11, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stains, Hematology
Device Class
Class I
Regulation Number
864.1850
Review Panel
PA
Submission Type

Other clearances by Anatech, Ltd.

  • K882874 — ZINC FORMALIN (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)
  • K872500 — ANATECH HEMATOXYLIN-EXTRA STRENGTH (July 9, 1987)
  • K870852 — NBF 10% NEUTRAL BUFFERED FORMALIN (March 31, 1987)
  • K842940 — CBA FORMALIN (August 28, 1984)
  • K842862 — CB FORMALIN (August 28, 1984)

Other clearances for product code KQC

  • K852843 — GENERAL DIAGNOSTICS COAG-A-MATE XC (August 13, 1985)
  • K843619 — RETIC-SET (October 30, 1984)
  • K841848 — RETIC-SET (May 31, 1984)
  • K792550 — PONCEAU S STAIN SET (January 16, 1980)
  • K792496 — VOLU-SOL NMB RETICULOCYTE STAIN (December 31, 1979)
  • K791007 — STAT DIFF STAIN (August 3, 1979)
  • K760487 — HEMASTAIN PHOSPHATE BUFFER (August 30, 1976)
  • K760485 — HEMASTAIN FIXATIVE (August 30, 1976)

FDA data resources