Polychrome IV Stain

FDA 510(k) K854176 · Devetec, Inc.

Substantially Equivalent

510(k) numberK854176

Submission

Device name
Polychrome IV Stain
Applicant
Devetec, Inc.
Bradenton, FL, US
Received
October 15, 1985
Decision date
October 31, 1985
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

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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
K860319MegacolorLED · Traditional Cytocolor, Inc.02/20/1986SE
K860317NeutrocolorLED · Traditional Cytocolor, Inc.02/20/1986SE
K860316PanoptikonLED · Traditional Cytocolor, Inc.02/20/1986SE
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
K894045Modified Polychrome IV StainKFD · Traditional 07/25/1989SE
K873594Tif Fecal TestLEA · Traditional 09/29/1987SE
K870988Price's Acid-Fast StainJTS · Traditional 03/30/1987SE

Questions and answers

When was Polychrome IV Stain cleared by the FDA?

Polychrome IV Stain (K854176) received a 510(k) decision of Substantially Equivalent on October 31, 1985, 16 days after the submission was received.

What is the product code of K854176?

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