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510(k) K881282

XYLENE by Anatech, Ltd. — Product Code KEM

K881282 is an FDA 510(k) premarket notification submitted by Anatech, Ltd. for the device "XYLENE". The FDA issued a decision of Substantially Equivalent on April 5, 1988. The device falls under product code KEM (Agent, Clearing), 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
April 5, 1988
Date Received
March 25, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Agent, Clearing
Device Class
Class I
Regulation Number
864.4010
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)
  • 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)
  • K842862 — CB FORMALIN (August 28, 1984)
  • K842940 — CBA FORMALIN (August 28, 1984)

Other clearances for product code KEM

  • K874461 — HEMO-SOL (December 4, 1987)
  • K861490 — PERMACLEAR SOLUTION CAT. NO. 4950 (May 6, 1986)
  • K855109 — CLEARENE, CLEARING AGENT (January 7, 1986)
  • K853694 — XYLENE SUBSTITUTE (October 22, 1985)
  • K854083 — XYLENE SUBSTITUTE MONTANT (October 22, 1985)
  • K842861 — PRO-PAR CLEARANT (August 21, 1984)
  • K842721 — LIMONENE (August 3, 1984)
  • K832011 — AMERI CLEAR (August 12, 1983)
  • K832451 — CLEAR-RITE 3 (August 12, 1983)
  • K830627 — CLARIFIER-RICHARD-ALLAN (March 24, 1983)

FDA data resources