Volu-Sol Bovins Fixative

FDA 510(k) K822129 · Volu Sol Medical Industries

Substantially Equivalent

510(k) numberK822129

Submission

Device name
Volu-Sol Bovins Fixative
Applicant
Volu Sol Medical Industries
Mchenry, IL, US
Received
July 19, 1982
Decision date
August 5, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
IGN – Fluid, Bouin'S
Device class
Class I (low risk)
Regulation
21 CFR 864.4010
Specialty
Pathology

Other 510(k)s with product code IGN

510(k)DeviceApplicantDecision
K833515Bouins SolutionIGN · Traditional Sigma Chemical Co.11/14/1983SE

More from Sigma Chemical Co.

510(k)DeviceDecision
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
K822038Volu-Sol Orange G-6(GILLS-MODHZH · Traditional 08/03/1982SE
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 Bovins Fixative cleared by the FDA?

Volu-Sol Bovins Fixative (K822129) received a 510(k) decision of Substantially Equivalent on August 5, 1982, 17 days after the submission was received.

What is the product code of K822129?

The FDA product code is IGN – Fluid, Bouin'S, a Class I (low risk) device regulated under 21 CFR 864.4010.