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510(k) K860319

MEGACOLOR by Cytocolor, Inc. — Product Code LED

K860319 is an FDA 510(k) premarket notification submitted by Cytocolor, Inc. for the device "MEGACOLOR". The FDA issued a decision of Substantially Equivalent on February 20, 1986. The device falls under product code LED (Stains, Chemical Solution), a Class I device regulated under 21 CFR 864.1850. Cytocolor, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 1986
Date Received
January 28, 1986
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 Cytocolor, Inc.

  • K860320 — GRANULOCOLOR (February 20, 1986)
  • K860317 — NEUTROCOLOR (February 20, 1986)
  • K860321 — LYSOCOLOR (February 20, 1986)
  • K860316 — PANOPTIKON (February 20, 1986)

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)
  • K860316 — PANOPTIKON (February 20, 1986)
  • K860320 — GRANULOCOLOR (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)
  • K842930 — GOMORI'S TRICHROME STAIN (September 11, 1984)

FDA data resources