Megacolor

FDA 510(k) K860319 · Cytocolor, Inc.

Substantially Equivalent

510(k) numberK860319

Submission

Device name
Megacolor
Applicant
Cytocolor, Inc.
Hinckley, OH, US
Received
January 28, 1986
Decision date
February 20, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
LED – Stains, Chemical Solution
Device class
Class I (low risk)
Regulation
21 CFR 864.1850
Specialty
Hematology

Other 510(k)s with product code LED

510(k)DeviceApplicantDecision
K051409SlivasureLED · Traditional Scandinavian Formulas, Inc.08/08/2005SE
K023046SST Saliva Supporting TabletsLED · Traditional Sinclair Pharmaceuticals, Ltd.12/02/2002SE
K860795Spottest Calcofluor White ReagentLED · Traditional Difco Laboratories, Inc.03/12/1986SE
K860321LysocolorLED · Traditional Cytocolor, Inc.02/20/1986SE
K860320GranulocolorLED · Traditional Cytocolor, Inc.02/20/1986SE
K860317NeutrocolorLED · Traditional Cytocolor, Inc.02/20/1986SE
K860316PanoptikonLED · Traditional Cytocolor, Inc.02/20/1986SE
K854176Polychrome IV StainLED · Traditional Devetec, Inc.10/31/1985SE
K851481Spottest Iodine Solution Dobell & O'ConnorLED · Traditional Difco Laboratories, Inc.04/29/1985SE
K842930Gomori's Trichrome StainLED · Traditional E K Ind., Inc.09/11/1984SE

More from E K Ind., Inc.

510(k)DeviceDecision
K860321LysocolorLED · Traditional 02/20/1986SE
K860320GranulocolorLED · Traditional 02/20/1986SE
K860317NeutrocolorLED · Traditional 02/20/1986SE
K860316PanoptikonLED · Traditional 02/20/1986SE

Questions and answers

When was Megacolor cleared by the FDA?

Megacolor (K860319) received a 510(k) decision of Substantially Equivalent on February 20, 1986, 23 days after the submission was received.

What is the product code of K860319?

The FDA product code is LED – Stains, Chemical Solution, a Class I (low risk) device regulated under 21 CFR 864.1850.