Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

VOLU-SOL DECALCIFER

K-Number: K822036 · 1982-08-03

ApplicantVolu Sol Medical Industries
Decision Date1982-08-03
Product CodeKDX
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

VOLU-SOL DECALCIFER is the device name listed in this FDA 510(k) record. The listed applicant is Volu Sol Medical Industries. It received FDA 510(k) clearance on 1982-08-03 under 510(k) number K822036. The device is classified under product code KDX. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VOLU-SOL DECALCIFER?

VOLU-SOL DECALCIFER is a medical device that received FDA 510(k) clearance on 1982-08-03. The listed applicant is Volu Sol Medical Industries. The 510(k) number is K822036.

When did VOLU-SOL DECALCIFER receive FDA 510(k) clearance?

VOLU-SOL DECALCIFER received FDA 510(k) clearance on 1982-08-03, under 510(k) number K822036.

Who is the listed applicant for VOLU-SOL DECALCIFER?

The FDA 510(k) record lists Volu Sol Medical Industries as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VOLU-SOL DECALCIFER?

The FDA product code for VOLU-SOL DECALCIFER is KDX.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Volu Sol Medical Industries as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K822128VOLU-SOL SINGLE DIFFERENTIAL STAINK822127VOLU-SOL ZENKERS FIXATIVEK822126VOLU-SOL CARNOY FLUIDK822129VOLU-SOL BOVINS FIXATIVEK822035VOLU-SOL GILLS EAK822038VOLU-SOL ORANGE G-6(GILLS-MOD

View all 66 devices →

Related Devices (Code: KDX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K872625DECALCIFYING SOLUTIONStephens ScientificK850636SIMUTANEOUS FIXATION & DECALCIFYING SOLUTION CAL-EFisher Scientific Co., LLCK842726DECALCIFIER SOLUTIONE K Ind., Inc.K841488DECALCIFIER ISurgipath Medical Industries, Inc.K821443FORMICALLerner Laboratories, Inc.K811801CAL-RITERichard-Allan Medical Ind., Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑