Orange G, 1%

FDA 510(k) K842924 · E K Ind., Inc.

Substantially Equivalent

510(k) numberK842924

Submission

Device name
Orange G, 1%
Applicant
E K Ind., Inc.
Mchenry, IL, US
Received
July 25, 1984
Decision date
September 7, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HZH – Orange G
Device class
Class I (low risk)
Regulation
21 CFR 864.1850
Specialty
Hematology

Other 510(k)s with product code HZH

510(k)DeviceApplicantDecision
K822038Volu-Sol Orange G-6(GILLS-MODHZH · Traditional Volu Sol Medical Industries08/03/1982SE
K811825Orange G-6HZH · Traditional Surgipath07/10/1981SE
K800323Volu-Sol Orange G-6 StainHZH · Traditional Volu Sol Medical Industries02/22/1980SE

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 Orange G, 1% cleared by the FDA?

Orange G, 1% (K842924) received a 510(k) decision of Substantially Equivalent on September 7, 1984, 44 days after the submission was received.

What is the product code of K842924?

The FDA product code is HZH – Orange G, a Class I (low risk) device regulated under 21 CFR 864.1850.