Home / 510(k) Clearances / K842861

510(k) K842861

PRO-PAR CLEARANT by Anatech, Ltd. — Product Code KEM

K842861 is an FDA 510(k) premarket notification submitted by Anatech, Ltd. for the device "PRO-PAR CLEARANT". The FDA issued a decision of Substantially Equivalent on August 21, 1984. 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
August 21, 1984
Date Received
July 23, 1984
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)
  • 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)

Other clearances for product code KEM

  • K881282 — XYLENE (April 5, 1988)
  • 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)
  • K842721 — LIMONENE (August 3, 1984)
  • K832451 — CLEAR-RITE 3 (August 12, 1983)
  • K832011 — AMERI CLEAR (August 12, 1983)
  • K830627 — CLARIFIER-RICHARD-ALLAN (March 24, 1983)

FDA data resources