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510(k) K882874

ZINC FORMALIN by Anatech, Ltd. — Product Code LDX

K882874 is an FDA 510(k) premarket notification submitted by Anatech, Ltd. for the device "ZINC FORMALIN". The FDA issued a decision of Substantially Equivalent on July 28, 1988. The device falls under product code LDX (Fixative, Metallic Containing), a Class I device regulated under 21 CFR 864.4010. 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
Fixative, Metallic Containing
Device Class
Class I
Regulation Number
864.4010
Review Panel
PA
Submission Type

Other clearances by Anatech, Ltd.

  • K882873 — FIELDTEX HEMATOXYLIN (July 28, 1988)
  • K882268 — ZINC FORMALIN CONCENTRATE (June 15, 1988)
  • K881282 — XYLENE (April 5, 1988)
  • K872663 — DRY-FORM (August 6, 1987)
  • K872500 — ANATECH HEMATOXYLIN-EXTRA STRENGTH (July 9, 1987)
  • K872498 — HARRIS HEMATOXYLIN (July 9, 1987)
  • K872499 — ANATECH HEMATOXYLIN-NORMAL 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)

FDA data resources