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510(k) K842727

SUPERMOUNT by E K Ind., Inc. — Product Code LED

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
Stains, Chemical Solution
Device Class
Class I
Regulation Number
864.1850
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)
  • K842937 — ACETIC ACID 2% V/V (September 12, 1984)
  • K842935 — ACETIC ACID, 5% V/V (September 12, 1984)
  • K842928 — JENNER BLOOD STAIN (September 11, 1984)
  • K842739 — PAP STAIN, EA-36 (September 11, 1984)
  • K842933 — CARBOL-FUCHSIN, ZIEHL-NEEDSEN (September 11, 1984)
  • K842927 — LIGHT GREEN SF 1% (September 11, 1984)

Other clearances for product code LED

  • K051409 — SLIVASURE (August 8, 2005)
  • K023046 — SST SALIVA SUPPORTING TABLETS (December 2, 2002)
  • K860795 — SPOTTEST CALCOFLUOR WHITE REAGENT (March 12, 1986)
  • K860320 — GRANULOCOLOR (February 20, 1986)
  • K860316 — PANOPTIKON (February 20, 1986)
  • K860319 — MEGACOLOR (February 20, 1986)
  • K860317 — NEUTROCOLOR (February 20, 1986)
  • K860321 — LYSOCOLOR (February 20, 1986)
  • K854176 — POLYCHROME IV STAIN (October 31, 1985)
  • K851481 — SPOTTEST IODINE SOLUTION DOBELL & O'CONNOR (April 29, 1985)