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510(k) K853694

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

K853694 is an FDA 510(k) premarket notification submitted by Lerner Laboratories, Inc. for the device "XYLENE SUBSTITUTE". The FDA issued a decision of Substantially Equivalent on October 22, 1985. The device falls under product code KEM (Agent, Clearing), a Class I device regulated under 21 CFR 864.4010. Lerner Laboratories, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 1985
Date Received
September 4, 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.

  • K854083 — XYLENE SUBSTITUTE MONTANT (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)
  • K854083 — XYLENE SUBSTITUTE MONTANT (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)

FDA data resources