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510(k) K854083

XYLENE SUBSTITUTE MONTANT by Lerner Laboratories, Inc. — Product Code KEM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 1985
Date Received
October 7, 1985
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 Lerner Laboratories, Inc.

  • K853694 — XYLENE SUBSTITUTE (October 22, 1985)
  • K821443 — FORMICAL (June 2, 1982)
  • K761000 — PAP-TRAY I (CATALOG #C600-1) (December 6, 1976)
  • K761001 — PAP-TRAY II (CATALOG #C600-2) (December 6, 1976)

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)
  • K842861 — PRO-PAR CLEARANT (August 21, 1984)
  • 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)