Volu-Sol Orange G-6(GILLS-MOD

FDA 510(k) K822038 · Volu Sol Medical Industries

Substantially Equivalent

510(k) numberK822038

Submission

Device name
Volu-Sol Orange G-6(GILLS-MOD
Applicant
Volu Sol Medical Industries
Mchenry, IL, US
Received
July 12, 1982
Decision date
August 3, 1982
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
K842924Orange G, 1%HZH · Traditional E K Ind., Inc.09/07/1984SE
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
K822129Volu-Sol Bovins FixativeIGN · Traditional 08/05/1982SE
K822128Volu-Sol Single Differential StainICN · Traditional 08/05/1982SE
K822127Volu-Sol Zenkers FixativeIFH · Traditional 08/05/1982SE
K822126Volu-Sol Carnoy FluidIGM · Traditional 08/05/1982SE
K822037Volu-Sol Tap Water SubstitutePPM · Traditional 08/03/1982SE
K822036Volu-Sol DecalciferKDX · Traditional 08/03/1982SE
K822035Volu-Sol Gills EaHZJ · Traditional 08/03/1982SE
K812906Elvi Biclot 816KQG · Traditional 07/22/1982SE
K821541Hematoxylin IIIHYJ · Traditional 06/10/1982SE
K821540Hematoxylin IIHYJ · Traditional 06/10/1982SE

Questions and answers

When was Volu-Sol Orange G-6(GILLS-MOD cleared by the FDA?

Volu-Sol Orange G-6(GILLS-MOD (K822038) received a 510(k) decision of Substantially Equivalent on August 3, 1982, 22 days after the submission was received.

What is the product code of K822038?

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