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510(k) K842721

LIMONENE by E K Ind., Inc. — Product Code KEM

K842721 is an FDA 510(k) premarket notification submitted by E K Ind., Inc. for the device "LIMONENE". The FDA issued a decision of Substantially Equivalent on August 3, 1984. The device falls under product code KEM (Agent, Clearing), a Class I device regulated under 21 CFR 864.4010. E K Ind., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1984
Date Received
July 13, 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 E K Ind., Inc.

  • K842931 — DRABKIN REAGENT (September 21, 1984)
  • K842938 — ACETIC ACID 1% V/V (September 14, 1984)
  • K842934 — DECOLORIZING FLUIC, ACID-ALCOHOL 3% (September 12, 1984)
  • K842936 — ACETIC ACID, 3% V/V (September 12, 1984)
  • K842935 — ACETIC ACID, 5% V/V (September 12, 1984)
  • K842937 — ACETIC ACID 2% V/V (September 12, 1984)
  • K842927 — LIGHT GREEN SF 1% (September 11, 1984)
  • K842731 — FORMALIN-ACETO-ALCOHOL FIXATIVE (September 11, 1984)
  • K842918 — SCOTTS TAP WATER SUBSTITUTE (September 11, 1984)
  • K842930 — GOMORI'S TRICHROME STAIN (September 11, 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)
  • K842861 — PRO-PAR CLEARANT (August 21, 1984)
  • K832451 — CLEAR-RITE 3 (August 12, 1983)
  • K832011 — AMERI CLEAR (August 12, 1983)
  • K830627 — CLARIFIER-RICHARD-ALLAN (March 24, 1983)

FDA data resources