Gentian Violet

FDA 510(k) K842730 · E K Ind., Inc.

Substantially Equivalent

510(k) numberK842730

Submission

Device name
Gentian Violet
Applicant
E K Ind., Inc.
Mchenry, IL, US
Received
July 13, 1984
Decision date
August 3, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
ICF – Crystal Violet For Histology
Device class
Class I (low risk)
Regulation
21 CFR 864.1850
Specialty
Hematology

Other 510(k)s with product code ICF

510(k)DeviceApplicantDecision
K864531Tissue Gram StainICF · Traditional Sigma Diagnostics, Inc.12/22/1986SE
K842537Von Willebrand Factor Antigen ScreenICF · Traditional American Dade10/01/1984SE
K821503Iris Urine StainICF · Traditional Intl. Remote Imaging Systems06/03/1982SE
K792495Volu-Sol Urinary Sediment StainICF · Traditional Volu Sol Medical Industries12/18/1979SE

More from Volu Sol Medical Industries

510(k)DeviceDecision
K842931Drabkin ReagentKAG · Traditional 09/21/1984SE
K842938Acetic Acid 1% V/VGGK · Traditional 09/14/1984SE
K842937Acetic Acid 2% V/VGGK · Traditional 09/12/1984SE
K842936Acetic Acid, 3% V/VGGK · Traditional 09/12/1984SE
K842935Acetic Acid, 5% V/VGGK · Traditional 09/12/1984SE
K842934Decolorizing Fluic, Acid-Alcohol 3%PPM · Traditional 09/12/1984SE
K842933Carbol-Fuchsin, Ziehl-NeedsenICL · Traditional 09/11/1984SE
K842930Gomori's Trichrome StainLED · Traditional 09/11/1984SE
K842928Jenner Blood StainKJX · Traditional 09/11/1984SE
K842927Light Green SF 1%HYS · Traditional 09/11/1984SE

Questions and answers

When was Gentian Violet cleared by the FDA?

Gentian Violet (K842730) received a 510(k) decision of Substantially Equivalent on August 3, 1984, 21 days after the submission was received.

What is the product code of K842730?

The FDA product code is ICF – Crystal Violet For Histology, a Class I (low risk) device regulated under 21 CFR 864.1850.